Recalls / Class II
Class IID-0775-2021
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
- Affected lot / code info
- 1408822A, exp. date 08/2023 (labeler - Casper)
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 4,587 bottles
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-27
- Posted by FDA
- 2021-09-08
- Terminated
- 2022-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0775-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.