Why it was recalled
cGmp Deviations
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.
Lot numbers, UPCs & expiration codes
Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0639-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 16, 2022
- FDA report date
- Mar 9, 2022
- Quantity
- 3672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0639-2022, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89607
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
- Postal code
- 08536-0009
- Report date
- Mar 9, 2022
- Product type
- Drugs
- Recall number
- D-0639-2022
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 3672 bottles
- Termination date
- Oct 16, 2023
- Reason for recall
- cGmp Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2022