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Class II · ModerateRecall completed

ATENOLOL Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 161901, Exp 04/18
Where it was soldProduct was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forThe 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;
NDC68645-493-54
Show the full FDA record
Full product labelATENOLOL 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.
Recalling firmLegacy Pharmaceutical Packaging LLC
DistributionProduct was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
Quantity48,012 bottles
Recall initiated2017-03-07
Report date2017-03-29
Recall completed2019-08-23
Recall numberD-0606-2017
ClassificationClass II
FDA statusTerminated
Origin on fileEarth City MO United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.