Recalls / Class III
Class IIID-0257-2024
Product
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
- Brand name
- Benzonatate
- Generic name
- Benzonatate
- Active ingredient
- Benzonatate
- Route
- Oral
- NDC
- 68084-214
- FDA application
- ANDA040597
- Affected lot / code info
- Lot # 1014208, Exp Mar/31/2025
Why it was recalled
Superpotent drug: Assay results were slightly above specification at the time zero point.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 6,344 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-12-26
- FDA classified
- 2024-01-19
- Posted by FDA
- 2024-01-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0257-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.