Drug 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.
D-0606-2017
Product summary
- Event
- Event 76666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,012 bottles
- Official record key
drug-enforcement:D-0606-2017
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 # 161901, Exp 04/18
Distribution pattern: Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets