FDA Recalls in 2021

two-bite chocolate cupcakes 10 oz. UPC 7 70981 04470 5

Potential for metal in product

Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 16 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00117 0. Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 32 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00116 3. Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 64 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00123 1. The Ingredients statement

Inhibitory substance was detected.

Hacienda Las Glorias Premium, Bebida de Parcha (Passion Fruit Drink) 16 Oz. (480 ML)

Undeclared Yellow #5

two-bite vanilla cupcakes 10 oz. UPC 7 70981 03109 5 284 g UPC 7 70981 73109 4 Bakery Fresh Goodness mini vanilla cupcakes 10 oz. UPC 0 11110 18230 2 NL Vanilla cupcakes 12PK - Everyday 03540 7.52 lbs. case UPC 1 07 70981 03540 3 7 Select vanilla mini cupcakes 10 oz. UPC 0 52548 62682 2 Best Choice Bakery vanilla two-bite cupcakes 10 oz. UPC 0 70038 66154 2 Sweet P's bake shop vanilla cupcakes 10 oz. 0 11225 12601 7 Freshness Guaranteed vanilla cupcakes 13.1 oz. UPC 0 78742 36760 6 Kimber

Potential for metal in product

two-bite unicorn cupcakes 10 oz. UPC 7 70981 04417 0 Marketside unicorn cupcakes 10 oz. UPC 6 81131 10125 7

Potential for metal in product

Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged in 64 oz glass bottle with a green cap, Refrigerated, UPC8 97605 00102 6. Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged in 32 oz glass bottle with a green cap, Refrigerated, UPC 8 97605 00105 7.

Inhibitory substance was detected.

Cesarina Cookies, Fiochetto, Apricot Raspberry Guava, Net Weight 16oz (453.59g)

Undeclared Milk

Favorite Day Bakery Frosted Sugar Cookies 13.5 oz. UPC 0 85239 41050 9

Potential for metal in product

two-bite apple caramel cupcakes 10 oz. UPC 7 70981 05550 3

Potential for metal in product

two-bite vanilla & chocolate cupcakes 10 oz. UPC 7 70981 03127 9 20 oz. UPC 7 70981 03104 0

Potential for metal in product

Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

Forbes AAC emailed the safety advisory notice to all customers on 10/11/2021. Letter states reason for recall, health risk and action to take: To utilize the USB power adapter safely and reduce the possibility of heat-related injury or damage, plug the power adapter directly into a power outlet. Don t use the power adapter in wet locations, such as near a sink, bathtub, or shower stall, and don t connect or disconnect the power adapter with wet hands. Avoid prolonged skin contact with the charging cable and connector when the charging cable is connected to a power source because it may cause discomfort or injury. Sleeping or sitting on the charging cable or connector should be avoided. Stop using the power adapter and any cables if any of the following conditions exist The power adapter plug or prongs are damaged. The charge cable becomes frayed or otherwise damaged. The power adapter is exposed to excessive moisture, or liquid is spilled into the power adapter. The power adapter has been dropped, and its enclosure is damaged. Current production has added a label to the charger brick warning customers not to use the charger if the cable is broken or damaged. States: WARNING: DO NOT USE CHARGER WITH DAMAGED OR BROKEN CABLES.

VIDAS PRG Progesterone, REF 30409-01

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to USFieldActions@biomerieux.com or Fax to: (919) 620-3306 to confirm receipt of this notice.

REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

On October 4, 2019, a "Urgent: Medical Device Recall" Letter was sent to all affected customers via US Mail. In addition to providing customers information on the recalled products, the letter asked customers to do the following: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-367-4703 (Monday - Friday, 8:00 am-5:00 pm ET) if you have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Please visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, ICU Medical will credit you for any product returned. You will only receive credit for product that you return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-367-4703 (M-F, 8am-5pm ET) to obtain a response form. 5) Replacement product is available. Please contact customer service using the information provided below. - Global Complaint Management - 1-844-654-7780 or ProductComplaintsPP@icumed.com, To report adverse events or product complaints - C

Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

On 04/30/2019, an Urgent Medical Device Letter was sent via mail to affected consignees. Customers were instructed to access the updated Instructions for Use (IFU) Limitations and Interferences sections for the six affected Access immunoassays on the firm's website. Additionally they ask customers to do the following: 1) Share the information with laboratory staff and retain the notification as part of their laboratory Quality System documentation. If any of the affected product(s) have been forwarded to another laboratory, they are to provide them with a copy of the Urgent Medical Device Recall letter. 2) Respond within 10 days either electronically (if received communication via email) or manually (complete and return an enclosed Response Form). If there are any questions regarding the notice, contact the Customer Support Center: website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact the local firm representative.

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

Medtronic distributed a correction notice via mail courier service to impacted U.S. consignees, delivered 06-October-2021. A second attempt to notify US consignees is scheduled for the week of 08-November-2021. A third attempt to notify US consignees is scheduled for the week of 10-Jan-2022. In addition to Medtronic s communications to Percept PC implanting and managing physicians, Medtronic will notify affected patients implanted with Percept PC INS devices of this issue in the US. US Patient notifications are scheduled to happen within a month s timeframe. Medtronic will retain delivery confirmations for all patient notification mailings.

da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A

Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.

On 09/22/2021, the firm notified affected customers via mail of "Urgent Medical Device Correction - ISIFA2021-04-C." The letter indicated, "As part of the field action process, please complete the actions below: 1. Ensure that all personnel who use the da Vinci SP System read and understand the contents of this letter. 2. Inform the personnel when the software update has been completed by the Intuitive representative. 3. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive as instructed on the form. 4. Retain a copy of this letter and the acknowledgement form for your files. 5. Contact Technical Support at the number listed below for assistance if you have experienced this issue: US Technical Support: 800-876-1310, Option 1 (24/7) An Intuitive representative will schedule a site visit to install the next available software update. If you require further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: -US Customer Service (800) 876-1310, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com."

FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.

On November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. Actions to be taken by the Customer/User: - Please inspect stock and quarantine impacted product. - Please discard any available inventory in your possession or by your customer s possession. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status. - Complete and return the attached response form via email at info@migotrading.com

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Superpotent Drug

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30

Superpotent; Hydrochlorothiazide

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.