Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- July 29, 2021
- Posted
- September 8, 2021
- Recall Number
- D-0774-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,655 bottles
- Firm Location
- Parsippany, NJ, United States
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
Product was distributed nationwide.
Lot / Code Info
1408821A, exp. date 08/2023 (labeler - Teva)
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