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Class II · ModerateRecall completed

Atenolol

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

Does this affect you?
Check your lot numberLot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
Where it was soldNationwide in the USA and Puerto Rico.
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

Made byCadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameATENOLOL
Generic nameATENOLOL
Active ingredient(s)ATENOLOL
Distributed by / forZydus Pharmaceuticals USA Inc., Pennington, NJ 08534
NDC68382-023-01
Show the full FDA record
Full product labelATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
Recalling firmZydus Pharmaceuticals USA Inc
DistributionNationwide in the USA and Puerto Rico.
Quantity9561 bottles
Recall initiated2017-03-06
Report date2017-03-29
Recall completed2019-11-05
Recall numberD-0605-2017
ClassificationClass II
FDA statusTerminated
Origin on filePennington NJ 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.