Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Reason Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Reason Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Reason Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Reason Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
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