Recalls / Class II
Class IID-0639-2022
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.
- Brand name
- Olanzapine
- Generic name
- Olanzapine
- Active ingredient
- Olanzapine
- Route
- Oral
- NDCs
- 33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072
- FDA application
- ANDA202862
- Affected lot / code info
- Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
Why it was recalled
cGmp Deviations
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 3672 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-02-16
- FDA classified
- 2022-02-28
- Posted by FDA
- 2022-03-09
- Terminated
- 2023-10-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0639-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.