Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
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 Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50…
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.
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