D-0776-2021 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
- 4,992 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 57237-266-01
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
1408824A, exp. date 08/2023 (labeler - Rising)