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.
Reported: March 9, 2022 Initiated: February 16, 2022 #D-0639-2022
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
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 3672 bottles
- Distribution
- Nationwide within the United States
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Macleods Pharma Usa Inc. Units affected: 3672 bottles.
Why was this product recalled? ▼
cGmp Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 9, 2022. Severity: Moderate. Recall number: D-0639-2022.
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