Recalls / Class II
Class IID-0605-2017
Product
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
- 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
- Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
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
- 9561 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-03-06
- FDA classified
- 2017-03-21
- Posted by FDA
- 2017-03-29
- Terminated
- 2019-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0605-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.