Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a manufacturing defect (microbial contamination via out-of-specification test results). No reported illnesses or injuries are stated in the source text, but the hazard is real rather than theoretical—excipient contamination in a systemically administered tablet poses an inherent risk of harm. Under the rubric, the absence of reported illness in a Class II recall with potential for harm qualifies as High severity.
Plain-English summary
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg, 100-count bottles (NDC 57237-266-01, manufactured by Actavis Laboratories FL, Inc.) due to Current Good Manufacturing Practice (CGMP) deviations.
The recall was initiated because an excipient batch of Dibasic Calcium Phosphate tested out of specification for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC). This indicates potential microbial contamination in the manufacturing ingredient.
Approximately 4,992 bottles with batch code 1408824A and expiration date 08/2023 (labeler: Rising) were distributed nationwide. Patients currently taking this medication should consult their healthcare provider or pharmacist before discontinuing use or seeking alternative treatments.
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 57237-266-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Muscle Relaxant
- 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)
- 1408824A
- exp. date 08/2023 (labeler - Rising)
Distribution
Distributed nationwide across the United States.
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