Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
FDA recall notice · announced March 9, 2022 · Macleods Pharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
Reason for recall
cGmp Deviations
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
Quantity: 3672 bottles
Status: Terminated
Products in this recall event:
- Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, In (D-0639-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.