Recalls / Class II
Class IID-0705-2017
Product
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
- Affected lot / code info
- 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
Why it was recalled
Microbial Contamination of Non-Sterile Products
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-24
- FDA classified
- 2017-05-11
- Posted by FDA
- 2017-05-17
- Terminated
- 2018-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0705-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.