Teva Pharmaceuticals USA: Drug Recall
Recall #D-0776-2021 · 07/29/2021
Class II: Risk
Recall Details
- Recall Number
- D-0776-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Teva Pharmaceuticals USA
- Status
- Terminated
- Date Initiated
- 07/29/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,992 bottles
Reason for Recall
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.
Product Description
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Distribution Pattern
Product was distributed nationwide.
Other Recalls by Teva Pharmaceuticals USA
- Class II: Risk 01/18/2022
- Class II: Risk 01/10/2022
- Class III: Low Risk 01/07/2022
- Class III: Low Risk 01/07/2022
- Class II: Risk 12/31/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.