FDA recall D-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.

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

Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2017-03-07

Report date

2017-03-29

Termination date

2019-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0606-2017