Recalls / Class II
Class IID-0007-2015
Product
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
- Brand name
- Atenolol
- Generic name
- Atenolol
- Active ingredient
- Atenolol
- Route
- Oral
- NDCs
- 68382-022, 68382-023, 68382-024
- FDA application
- ANDA076900
- Affected lot / code info
- MP2292 Exp. 01/16
Why it was recalled
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 5400 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-05
- FDA classified
- 2014-10-03
- Posted by FDA
- 2014-10-15
- Terminated
- 2017-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.