Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Reported: September 8, 2021 Initiated: July 29, 2021 #D-0775-2021
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 70199-014-01
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 4,587 bottles
- Distribution
- Product was distributed nationwide.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01. Recalled by Teva Pharmaceuticals USA. Units affected: 4,587 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 8, 2021. Severity: Moderate. Recall number: D-0775-2021.
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