December 2023 – 12/17 – 12/23 – 13 Recalls (12 FDA, 1 USDA)

Current FDA & USDA Recall Trends

FDA

Recall / Contributing Factor(s)

  • 12/23/23 – Food & Beverage – Beer Battered Pollock and Cod Fillets – Undeclared Soy.
    • “NO ILLNESSES HAVE BEEN REPORTED TO DATE. THE RECALL WAS INITIATED AFTER IT WAS DISCOVERED THAT PRODUCT CONTAINING SOY WAS DISTRIBUTED IN PACKAGING THAT DID NOT REVEAL THE PRESENCE OF SOY.” 1
  • 12/22/23 – Drugs – Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial – Presence of Glass Particulate Matter.
    • “The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial.” 2
  • 12/22/23 – Drugs – Benzocaine Topical Anesthetic Spray – Presence of benzene.
    • “Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can.” 3
  • 12/21/23 – Food & Beverage – Burnt Caramel Candy Bars – Potential Allergen – Undeclared Coconut.
    • “The recall was initiated after it was discovered that the coconut-containing product was distributed in packaging that did not reveal the presence of coconut.” 4
  • 12/21/23 – Medical Devices – Masks with magnets – Potential for magnetic interference near certain implants and medical devices.
    • “ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require a return of a mask with magnets unless the patient is contraindicated. All ResMed masks containing magnets are safe when used in accordance with the Field Safety NoticeExternal Link Disclaimer and updated Instructions for Use in the guides of affected masks. 5
  • 12/21/23 – Animal & Veterinary – Kitten Grind, Kitten Mix, and Puppy Mix – Potential contamination of Salmonella and Listeria monocytogenes.
    • “On 12/15/2023 the firm was notified by the North Carolina Department of Agriculture and Consumer Services that one lot of each of the products were sampled and tested positive for Salmonella and Listeria monocytogenes. However, out of an abundance of caution the firm is recalling all lots with the used by dates between N24 1114 to N24 1224.” 6
  • 12/20/23 – Food & Beverage – Various Deli Salads – Product may be contaminated with Listeria monocytogenes.
    • “Out of an abundance of caution Herold’s Salads of Cleveland is recalling assorted deli salads packaged in various sizes. Recalled products may be contaminated with Listeria monocytogenes.” 7
  • 12/20/23 – Medical Devices – Tracheostomy Care and Cleaning Trays – Device & Drug Safety – Potential Component Defect.
    • “Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture tubing during use and/or cause user injury during handling. In addition, complaints describe bristles of the tracheostomy brush detaching before and potentially during use. If bristles reach a patient’s airway, they may cause unexplained increases in sputum or pulmonary secretions, signs of infection, or difficulty breathing. If a patient exposed to the brush experiences any of these signs or symptoms, they should seek medical attention promptly. To date, Medline Industries, LP. has received one adverse event associated with this product.” 8
  • 12/20/23 – Medical Devices – Medical Device Kits and Trays – Device & Drug Safety – Potential Lack of Sterility.
    • “On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.” 9
  • 12/19/23 – Food & Beverage – Raspberry Kringle Danish – Undeclared Allergen – Pecans.
    • “The recall was initiated when a customer discovered that a Raspberry Kringle containing pecans was distributed in packaging that did not reveal the presence of pecans.” 10
  • 12/19/23 – Food & Beverage – Gift Baskets with Quaker Chewy Granola Bars – Potential Salmonella contamination.
    • “Wine Country Gift Baskets / Houdini Inc. of Fullerton, CA is taking precautionary measures of voluntarily recalling all gift baskets produced with Quaker Chewy Granola bars due to a recall by the Quaker Oats company because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.” 11
  • 12/18/23 – Drugs – Vigabatrin for Oral Solution, USP 500mg – Due to seal integrity issues allowing for powder leakage from the pouch.
    • “Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from the pouch.” 12

USDA

  • 12/22/23 – Food – Ground Beef – Possible contamination with coli O103
    • “The problem was discovered during routine FSIS testing and the sampling results showed the presence of coli O103. There have been no confirmed reports of illness due to consumption of these products.” 13

 

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tampa-bay-fisheries-inc-dover-florida-voluntarily-recalling-1-lot-365-whole-foods-market-beer

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bleomycin-injection-usp-15-units-single-dose

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-americainer-20-benzocaine-topical

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astor-chocolate-corporation-issues-allergy-alert-undeclared-coconut-burnt-caramel-bars

5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resmed-notifies-customers-about-updated-instructions-and-labeling-masks-magnets-due-potential

6 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blue-ridge-beef-issues-voluntary-recall-blue-ridge-beef-kitten-grind-blue-ridge-kitten-mix-and-blue

7 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/herolds-salads-inc-voluntarily-recalls-assorted-deli-salads-due-possible-contamination-listeria

8 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-voluntary-nationwide-recall-various-lots-tracheostomy-care-and-cleaning

9 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based

10 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rdk-corp-dba-racine-danish-kringles-issues-allergy-alert-potential-undeclared-pecans-14oz-raspberry

11 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/houdini-inc-recalls-gift-baskets-quaker-oats-chewy-granola-bars-because-possible-health-risk

12 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/invagen-pharmaceuticals-issues-voluntary-nationwide-recall-vigabatrin-oral-solution-usp-500mg-due

13 https://www.fsis.usda.gov/recalls-alerts/scanga-meat-company-recalls-ground-beef-products-due-possible-e–coli-o103

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