FDA-Drug2021-09-08Class II
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
Teva Pharmaceuticals USA
Hazard
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.
Sold states
Product was distributed nationwide.
Affected count
9,655 bottles
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0774-2021Don't want to check this manually?
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