Teva Pharmaceuticals USA recalls 7.5mg cyclobenzaprine tablets due to microbial contamination in an excipient batch. Affected products have NDC 57237-266-01 or 1408824A, expiring 08/2023. No remedy specified in 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 recall affects products with specific NDC numbers and expiration dates.
The recall is due to out-of-specification test results for microbial counts in an excipient batch. This means the tablets may contain higher levels of bacteria or mold than safe. While the exact health risk isn't specified, such contamination could lead to infections or other health issues if the tablets are taken.
Prescription owners of the recalled cyclobenzaprine tablets with NDC 57237-266-01 or 1408824A, expiring 08/2023. People taking these medications for muscle pain or spasms are most at risk.
Check for the NDC numbers 57237-266-01 or 1408824A on the product label. The tablets are 7.5mg, 100-count, prescription-only, and expire by August 2023.
Look for NDC numbers 57237-266-01 or 1408824A on the tablet packaging.
The recall is due to out-of-specification test results for microbial counts in an excipient batch, which may indicate contamination.
The recall notice does not specify a remedy, so you should check the product label and contact your healthcare provider for guidance.
The recall notice does not specify the exact health risks, but microbial contamination could pose a health risk if the tablets are taken.
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-0776-2021 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0776-2021 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.
