ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth

FDA recall notice · announced March 29, 2017 · Legacy Pharmaceutical Packaging

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.

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.

Notes

Distribution: Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
Lot/code information: Lot # 161901, Exp 04/18
Quantity: 48,012 bottles
Status: Terminated
Products in this recall event:
- ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; (D-0606-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.