Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
Lot numbers, UPCs & expiration codes
100 (NDC 0093-4359-01) and 500 count bottles (NDC 0093-4359-05)- Lot # 07C160; Exp. 03/18 100 Unit Dose Blisters/Carton (NDC 0093-4359-93) and Individual Blister Pack (NDC 0093-4359-19) - Lot # 07C160A; Exp. 03/18
Where it was sold
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-0705-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2017
- FDA report date
- May 17, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0705-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77109
- Address
- 1090 Horsham Rd
- Code information
- 100 (NDC 0093-4359-01) and 500 count bottles (NDC 0093-4359-05)- Lot # 07C160; Exp. 03/18 100 Unit Dose Blisters/Carton (NDC 0093-4359-93) and Individual Blister Pack (NDC 0093-4359-19) - Lot # 07C160A; Exp. 03/18
- Postal code
- 19454-1505
- Report date
- May 17, 2017
- Product type
- Drugs
- Recall number
- D-0705-2017
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Termination date
- Feb 2, 2018
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 24, 2017
- Initial firm notification
- Letter
- Center classification date
- May 11, 2017