D-0639-2022 Class II Terminated
FDA drug recall D-0639-2022 was initiated by Macleods Pharma Usa Inc on February 16, 2022 and is designated Class II. Reason for recall: cGmp Deviations The recall status is terminated (terminated October 16, 2023). Affected quantity: 3672 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 9, 2022
- Initiation Date
- February 16, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3672 bottles
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022