Reported Mar 9, 2022 · Terminated

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ…

Macleods Pharma 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: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009

Is this the product you have?

  • Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only
  • Manufactured forMacleods Pharma USA , Inc. Plainsboro, NJ 08536
  • Manufactured byMacleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07
Lot codes and dates
    • Lot #: BOB42029A
    • BOB4202B
    • Exp. Date 09/2022
Amount recalled
3672 bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

cGmp Deviations

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 Oct 16, 2023 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.