2024 Product Recalls

Overloaded Electrical System May Cause Fire

Overloaded electrical circuits can overheat, increasing the risk of fire.

Dealers will update the firmware, free of charge. Owner notification letters are expected to be mailed January 22, 2024. Owners may contact Alexis Fire customer service at 1-309-482-6121.

Overloaded Electrical System May Cause Fire

Overloaded electrical circuits can overheat, increasing the risk of fire.

Dealers will update the firmware, free of charge. Owner notification letters were mailed January 25, 2024. Owners may contact PL Custom customer service at 1-732-223-1411.

Inoperative Left Rear Turn Signal

A nonfunctioning exterior turn signal may not notify other drivers of a turning vehicle, increasing the risk of a crash.

The CEM software will be updated by a dealer or through an over-the-air (OTA) update, free of charge. Owner notification letters were mailed February 16, 2024. Owners may contact Volvo Car customer service at 1-800-458-1552. Volvo Car's number for this recall is R10256.

Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

Lack of Sterility Assurance

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

Racine Danish Kringles Raspberry Kringle, 14 oz. UPC 0 45251-00312 7. RDK Corp, Racine, WI 53404.

Raspberry Kringle may contain undeclared tree nuts (pecans).

Sung Soy Bean Sprouts, 1lb packages, in plastic packages, 20 bags per case

The firm initiated a recall of SoyBean Sprouts because product tested positive for Listeria monocytogenes.

Scratch PASTA Co MARINARA SAUCE NET WT. 24.5 oz glass jar Ingredients: San Marzano Plum Peeled Tomatoes, Onion, Butter (Cream, Natural Flavor) UPC 8 50053 68700 6 Scratch Pasta Company 2204 Bedford Avenue, Suite E Lynchburg, Virginia 24503

During a contract inspection by the North Carolina Department of Agriculture, NCDA, informed the firm that the labeling does not list the common name of "milk".

Spring Valley Biotin & Collagen Liquid, Natural Berry Flavor, 15000 mcg, Dietary Supplement 29 doses 1 fl oz (29mL) UPC: 194346065158 Packaged in a glass bottle in a paper carton

Potential mold contamination

Pamana Premium Marinated Bangus (Deboned Marinated Milkfish), Net Weight to be Weight at Time of Sale

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use.").

Bobo's Oat Bars - Peach 3oz packaged in ALOX coated PET film, corrugate cartons and master case. 12 units per carton

Undeclared Allergen - Coconut

Pamana Premium Marinated Baby Bangus (Deboned Marinated Baby Milkfish), Net Weight to be Weight at Time of Sale

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use.").

Pamana Premium Bangus Belly (Cut Deboned Milkfish Belly), 340 g (120 oz)

Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use.").

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

Due to product label/labeling being altered from it's approved state.

On 11/11/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" notification letter to customers informing them they discovered that the labeling sent to customers were not the approved version of the product labeling. The labeling was missing the following items; warnings, cautions, precautions, anticipated adverse events, indication for use, contraindications, software overview and software description. The incorrect labeling could result in the following risks/hazards/harms: - A lack of understanding of the Indications for Use of this software. - Use of the software by someone who is not a dental professional and does not have a thorough understanding of the dentistry and orthodontic principles, clinical applications, and risks. - The improper use of poor-quality dental scans as an input for treatment planning. - The lack of knowledge of the tools available for use during collision detection. - The sale of this product to someone other than a dental professional. - The user not knowing that they needed the necessary product training to use the software. - A lack of understand that a failure to observe all warnings and precautions may result in complications. - A lack of knowledge of theoretical adverse events that could result during sequential aligner treatment, after using this software. - A lack of knowledge regarding the technical description of the product. - A lack of knowledge regarding the technical requirements of the system. - Poor fit, possibly resulting in: ++ Poor fit ++ Infection ++ TMD ++ Crown Removal - Inappropriate tooth movements, including: ++ Nerve Damage ++ Pulpal Degradation ++ Gingival Recession ++ Root Resorption ++ Tooth Extrusion ++ Tooth Loss ++ Unintended tooth movement Customer are informed to: 1) Read the document (MKT-LB-005) that is included with the the customer notification. The document includes all information missing from the label sent with the delivery of the product. 2) Send a read receipt associated with the ema

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency.

On 02/01/2021, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Notification Letter to inform customers that the Recalling Firm has identified that there is a software anomaly in the Analyzer Software subcomponent called Suhaili Service (version 2.0.3 and earlier) that is affecting the Analyzer. Suhaili Service controls raw data processing based on assay configuration data from Sample Prep software. Processed results are sent to Sample Prep software for patient result reporting. This anomaly, as a result of this interface, has a potential risk of reporting wrong patient results for Vitamin D. Customers are informed, As an immediate correction the following instructions must be followed with Cascadion SM Clinical Analyzer Software versions 2.0.2 and earlier until the installation of the new software version 2.1. 1. Please distribute this information immediately to any staff that may be impacted by this issue. 2. Please change the Quick Connect Cartridge Cs on the instrument to new ones. 3. After the cartridge change, if a sample is reported to have concentration of total 25-hydroxy Vitamin D below assay measuring range, follow these instructions to prevent the error from being reported: a. Repeat the sample analysis with a Cascadion SM Clinical Analyzer b. In case the repeated result is below assay measuring range, the sample should be rerun on another assay and platform. 4. Retain a copy of this letter for your laboratory records. 5. As appropriate, contact your Medical Professional for evaluation of further action. 6. Please, fill out the MEDICAL DEVICE RECALL- Response Form and return it within 5 days of the date of this letter to your manufacturer as instructed in the form and as listed: Email: vigilance.clinical.fi@thermofisher.com The actions to be taken by the Recalling Firm: 1. The Recalling Firm has informed the appropriate Regulatory Agencies. 2. When, available, the final corrective action will be to update Clinical Analyzer software v2.1

Wegmans Seafood Medley, 1lb.

May contain plastic foreign object