Drug 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.
D-0605-2017
Product summary
- Event
- Event 76673
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9561 bottles
- Official record key
drug-enforcement:D-0605-2017
Official wording
Reason: Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Code information: Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets