D-0774-2021 Class II Terminated
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
- 9,655 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, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
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
1408821A, exp. date 08/2023 (labeler - Teva)