D-0775-2021 Class II Terminated
FDA drug recall D-0775-2021 was initiated by Teva Pharmaceuticals USA on July 29, 2021 and is designated Class II. 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. The recall status is terminated (terminated November 4, 2022). Affected quantity: 4,587 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 8, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- November 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,587 bottles
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 70199-014-01
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.
Distribution Pattern
Product was distributed nationwide.
Code Information
1408822A, exp. date 08/2023 (labeler - Casper)