D-0605-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2017
- Initiation Date
- March 6, 2017
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9561 bottles
Product Description
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.
Reason for Recall
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18