Teva Pharmaceuticals USA recalls 7.5mg Cyclobenzaprine tablets with potential microbial contamination from a manufacturing batch defect. Affected products have specific NDC numbers and expiration dates. Consumers should contact the company for details.
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 Hydrochloride tablets that may have microbial contamination from a manufacturing batch. This could pose a health risk if the tablets are taken.
The tablets were manufactured with a batch of Dibasic Calcium Phosphate that failed quality tests for microbial counts. This could mean the tablets contain harmful bacteria or mold that might cause illness if taken.
People who have the specific 7.5mg Cyclobenzaprine tablets with NDC numbers 0591-3330-01 or 1408821A, expiring 08/2023, and are prescribed by a doctor. Those who have taken these tablets without medical supervision are not affected.
Check for the product name 'Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count' with NDC numbers 0591-3330-01 or 1408821A, and an expiration date of 08/2023. The product is prescription-only and distributed by Teva.
Look for the NDC numbers 0591-3330-01 or 1408821A and expiration date 08/2023 on the bottle.
The recall is due to potential microbial contamination from a manufacturing batch defect. If you have the specific product with the NDC numbers mentioned, you should not take it until you get further instructions.
The recall record does not specify a remedy, so contact Teva Pharmaceuticals USA directly for guidance.
Check the NDC numbers 0591-3330-01 or 1408821A and expiration date 08/2023 on the product label.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0774-2021 — Teva Teva Hello, I own a Teva that is covered by recall D-0774-2021 from Teva. 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.
