FDA Recalls in 2020

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

CGMP Deviations

Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232

Subpotent drug.

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8

The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.

CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt, wheat starch, raising agent: E500ii, palm oil, salt, vanilla flavoring 17%, cocoa butter, emulsifier (soy lecithin), natural vanilla extract; This product may contain traces of nuts, egg protein, peanut and lupine; Net Weight. 5oz

Product contains undeclared milk.

Organic fresh cut basil packaged in plastic clamshell containers The Fresh Market Organic Basil NET WT 0.5oz (14g), UPC:7-37094-23027-2 Good & Gather organic basil NET WT 0.5oz (14.17g), UPC:0-85239-12215-0 Naturally Better Organic Fresh Cut Basil 0.5oz (14g), UPC:6-07880-20230-4 Naturally Better Organic Fresh Cut Basil 0.5oz (14g) UPC: 6-07880-20230-4 Naturally Better Organic Fresh Cut Basil 0.5oz (14g), UPC:6-07880-20230-4 Nature Promise Organic Basil NET WT 4 OZ (113g), UPC:6-88267-16

Possible contamination with Cyclospora

Organic Basil,15 bags, Net. Wt.15Lbs case.

Possible contamination with Cyclospora

Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3

CCP deviation with the wash process

Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8

Product mis-packaging which lead to undeclared milk

Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Ensuring affected personnel are aware of the notice contents - Assisting the Zimmer Biomet sales representative with the quarantine of the affected products. Certificate of Acknowledgement complete and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC. Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed. Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Complete the enclosed faxback form and return it following the instructions on the form. File this UMDC for future reference. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.

AC Powered hospital adjustable bed.

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

The firm sent a Medical Device Recall-User Manual letter dated May 4,2020 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify affected units. Units bearing the options numbers OL360011P or OL360017P and manufactured between January 26th, 2015 and January 24rd,2020 were packaged with a User Manual affected by this recall and subject to improvement with the attached addendum. A list of serial numbers traced as being in your facility is attached to this communication. The manufacturing date and serial number are located on the manufacturer label located at the head end of the device. Actions Needed: 1. Please carefully read the attached addendum and promptly disseminate its contents to all concerned personnel in your facility, including more importantly to all persons who are or may be called upon to use/operate the bed. 2. Locate the User Manual related to your FL36 bed and insert the addendum, for future reference, in the appropriate section of the instruction manual for the FL36 ook-snow, ook-snow MH or ook-cocoon beds. 3. If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. 4. If you have disposed of any of the affected beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. 5. Call at 1-844-409-4030 or at 1-418-247-3986, extension 4 to confirm that your facility received Umano Medical Inc.s addendum to the User Manual regarding the Zeroing Procedure and the Detection System applicable to the above-mentioned product(s) and that the Actions Needed have been taken and completed by your facility.

CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00200 3

The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.

True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, 12 bags per case-pack

Product may contain nightshade

Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S

May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

Medtronic issued Urgent Medical Device Recall letter by letter delivered via Federal Express and/or certified mail beginning November 23, 2020. The letter states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed above. 2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3. If you have distributed the Covidien TA" Auto Suture" Vascular Stapler and Loading Unit with DST Series" Technology listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory We request that you contact Medtronic if you experienced a quality problem or adverse event. Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

On December 20, 2018, Terrific Care, LLC. / Medex Supply Dist, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter (dated 12/19/18) of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/telephone/facsimile orders. On December 21, 2018, Terrific Care, LLC / Medex Supply Dist, Inc. re-issued an Amended Press Release identifying affected Catalog Numbers and lots. On December 26, 2018, recall notices were issued to customers via email. On or about January 29, 2019, Terrific Care, LLC. / Medex Supply Dist, Inc. re-issued Urgent Medical Device Recall and Response Forms to customers. Actions Required: 1) Immediately stop using and quarantine all CoaguChek XS Test Strips sold by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/phone orders/facsimile. 2) If you have product to return, please send an E-Mail to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between the hours of 9:00 am - 5:00 pm, Monday - Thursday. 3) Include your order ID, and insert - Recall- in the email subject line. 4) Complete and return the attached response form via email. 5) For reimbursement, contact Terrific Care by phone at 888-433-2300 or by email at RMA@medexsupply.com. - Patients, caretakers and health care providers should switch to new batches of CoaguCheck XS P Test Strips. New batches should be obtained by contacting Roche Diagnostics Corporation at 1-800-428-4674. -Patients who are using devices affected by the recall should contact their health care providers immediately to determine an alternative testing method while waiting for replacement strips that are not affected.

Zoll M Series External Defibrillator

Defibrillator may fail to charge or hold its charge above energies of 75 joules

Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

On 12/8/2020, Medtronic sent an "Urgent: Medical Device Recall" Notification via FedEx to affected consignees. In addition, to providing consignees information on the recall device, Medtronic ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected products within your inventory. The list of affected lots is included. 2. Contact Medtronic to return affected product and receive replacement(s). See instructions on next page. 3. Please complete and return the customer confirmation form, even if you do not have any affected product 4. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: - E-mail Medtronic at RS.MNSProdExperienceHelp@Medtronic.com or call 1-877-526-5432. Online at the FDA website1 (form available to fax or mail) or call FDA at 1-800-FDA-1088.

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue

The bone screw is shorter than the intended design specification.

The recalling firm, TriMed, issued a "URGENT MEDICAL DEVICE RECALL" letter via email on 8/24/2018 to the distributors and third-party distributor. A follow-up letter was issued 3/28/2019 requesting downstream customers be notified to the user level. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If the customer further distributed Hex Cortical Screws, 4.0mm that is the subject of this recall, to forward the letter and the return response card to those entities that utilized the impacted product. " If the customer utilized the Hex Cortical Screws, 4.0mm that is the subject of this recall, then the customer is to: o Review customer inventory (including any kits that you have prepared for surgical operation) to see if they have any of the impacted product. o If a customer does have impacted product within its inventory, remove the product from use. o Review customer records to see if the impacted product was implanted. If the customer has records that impacted product was implanted, the customer should apply medical judgment to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. o Return to TriMed a return response card by 11 April 2019. Please email the response to: quality@trimedortho.com. Please contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221 or Email: quality@trimedortho.com * Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays).

Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77

Failed Dissolution Specifications

Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01

Subpotent drug

B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden

Cross contamination: the excipient was found to be contaminated with theophylline.

Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.

Subpotent drug

Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897

Subpotent drug

GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.