Drug product

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

D-0774-2021

July 29, 2021

Class II

Product summary

Firm: Teva Pharmaceuticals USA
Event: Event 88370
Status: Terminated
Classification: Class II
Quantity: 9,655 bottles
Official record key: drug-enforcement:D-0774-2021

Official wording

Reason: 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.

Code information: 1408821A, exp. date 08/2023 (labeler - Teva)

Distribution pattern: Product was distributed nationwide.

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of specification