Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a CGMP deviation involving microbial contamination of an excipient. The source text does not report any illnesses or injuries, and the hazard is based on out-of-specification test results rather than confirmed contamination or adverse events. Per the rubric, recalls with no reported illnesses and theoretical hazards are typically scored at 2 (Moderate) for manufacturing deviations.
Plain-English summary
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count bottles (NDC 70199-014-01) manufactured by Actavis Laboratories FL, Inc. The recall affects approximately 4,587 bottles with lot number 1408822A and expiration date 08/2023 (labeled as Casper).
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Testing of an excipient batch of Dibasic Calcium Phosphate used in the product showed out-of-specification results for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).
The product was distributed nationwide. Patients taking this medication should consult their healthcare provider before discontinuing use or switching to an alternative. Healthcare providers and pharmacies should stop dispensing affected lots immediately and quarantine remaining inventory.
The recalled product
- Product
- 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
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Tablet / Oral
- Hazard
- microbial-contamination
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 1408822A
- exp. date 08/2023 (labeler - Casper)
Distribution
Distributed nationwide across the United States.
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