D-0606-2017 Class II Terminated
FDA drug recall D-0606-2017 was initiated by Legacy Pharmaceutical Packaging LLC on March 7, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 23, 2019). Affected quantity: 48,012 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- August 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,012 bottles
Product Description
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.
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.
Code Information
Lot # 161901, Exp 04/18