Teva Pharmaceuticals USA recalls 7.5mg cyclobenzaprine tablets due to potential microbial contamination in an excipient batch. Affected products have NDC 70199-014-01 or 1408822A, expiring 08/2023. No specific remedy is stated in the recall notice.
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Teva Pharmaceuticals USA is recalling 7.5mg cyclobenzaprine tablets that may contain microbial contamination from an excipient batch. This could pose a health risk if the tablets are taken without proper testing.
The tablets were manufactured using an excipient batch that tested out of specification for microbial counts. This means the tablets could contain harmful bacteria or mold that might cause illness if taken.
People who have prescription cyclobenzaprine tablets with NDC 70199-014-01 or 1408822A, expiring 08/2023, are affected. Those taking the medication for muscle pain or spasms are most at risk.
Check the product label for NDC 70199-014-01 or 1408822A, and the expiration date of 08/2023. The product is a prescription-only 7.5mg cyclobenzaprine tablet bottle.
Look for NDC 70199-014-01 or 1408822A on the label and expiration date 08/2023.
The recall is due to potential microbial contamination from an excipient batch that tested out of specification for total aerobic microbial count and total yeast and mold count.
The recall notice does not specify a remedy, so contact your healthcare provider for advice on whether to use the product.
Yes, the product expires on 08/2023.
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0775-2021 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0775-2021 from Teva Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
