July 14, 2024 – July 20, 2024 -6 Recalls (5 FDA, 1 USDA)

Industries: Drugs, Medical Devices, Dietary Supplements, Produce, RTE Meat

Current FDA & USDA Recall Trends

FDA

Recalls / Contributing Factor(s)

  • 7/17/24 – Drugs – Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets – Mislabeled with the incorrect strength on the carton.
    • “The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.” 1
  • 7/16/24 – Dietary Supplements – Infla-650 Herbal Dietary Supplement Capsules – Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone.
    • “FOR IMMEDIATE RELEASE – 07/16/2024 – Lilburn, GA, GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone, which are not listed on the label. Products containing acetaminophen, diclofenac and phenylbutazone cannot be marketed as dietary supplements. Infla-650 Herbal Dietary Supplement Capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.” 2
  • 7/16/24 – Food & Beverage – whole cucumbers and bagged salad – Potential to be contaminated with Listeria monocytogenes.
    • “Willard, OH (July 12, 2024) – Out of an abundance of caution, Wiers Farm Inc. of Willard, OH, is voluntarily recalling a limited number of whole cucumbers with a pack date of June 5, 2024 and bagged salad cucumbers with a pack date of June 5, 2024 and June 6, 2024 due to possible contamination with Listeria monocytogenes. This product was not grown or harvested by Wiers Farm. It was sourced from out of state, then handled and distributed by Wiers Farm. Wiers Farm Inc. is coordinating closely with regulatory officials in connection with the recall.” 3
  • 7/16/24 – Medical Devices – Volara system single-patient use circuit and blue ventilator adapter assembly – Reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter.
    • “DEERFIELD, Ill., July 15, 2024 – Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly (see Figure 1). The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no injuries reported in association with this issue. Baxter is working with customers to replace the affected products.” 4
  • 7/15/24 – Drugs – Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg – Tainted with the drug ingredients, diclofenac and omeprazole.
    • “FOR IMMEDIATE RELEASE – 7/15/2024 – Chula Vista, CA, SoloVital.com is voluntarily recalling all lots of Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole drug cannot be marketed as dietary supplements. Umary is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.” 5

USDA

  • 7/15/24 – Food – Ready-to Eat Hot Dog Products – Without the benefit or inspection.
    • “The problem was discovered when FSIS was notified by a state public health partner about these products. FSIS investigated and determined that the hot dog products were produced and distributed without the benefit of federal inspection.” 6

 

1 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp

2 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/guru-inc-issues-voluntary-nationwide-recall-infla-650-herbal-dietary-supplement-capsules-due-hidden

3 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria

4 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-recall-volara-system-single-patient-use-circuit

5 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/solovitalcom-issues-voluntary-nationwide-recall-umary-acido-hialuronica-suplemento-alimenticio-850

6 https://www.fsis.usda.gov/recalls-alerts/aw-farms-recalls-ready-eat-hot-dog-products-produced-without-benefit-inspection

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