Recalls / Class II
Class IID-0606-2017
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.
- Affected lot / code info
- Lot # 161901, Exp 04/18
Why it was recalled
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 13333 Lakefront Dr, Earth City, Missouri 63045-1514
Distribution
- Quantity
- 48,012 bottles
- 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.
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2017-03-21
- Posted by FDA
- 2017-03-29
- Terminated
- 2019-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0606-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.