Reported Mar 29, 2017 · Terminated

ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • ATENOLOL 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 byCadila Healthcare Ltd., India
  • Distributed byZydus Pharmaceuticals USA Inc., Pennington, NJ 08534
Lot codes and dates
    • Lot #: a) Z600724
    • Exp 04/18
    • Z600725
    • Exp 04/18
Amount recalled
9561 bottles

Where it was sold

  • Nationwide
  • PR

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 5, 2019 · Data as of Sep 19, 6:29 PM UTC

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