Why it was recalled
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Product description
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Lot numbers, UPCs & expiration codes
Lot #: CZSC20003-A, Exp 1/2022
Where it was sold
U.S.A. Nationwide
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-1370-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 1440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1370-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85852
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: CZSC20003-A, Exp 1/2022
- Postal code
- 08520-1401
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1370-2020
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 1440 bottles
- Termination date
- Dec 21, 2022
- Reason for recall
- Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jun 12, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 30, 2020