Recalls / Class II
Class IID-0082-2019
Product
Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
- Affected lot / code info
- Lot # 34033752A, EXP 1/2020
Why it was recalled
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
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
- 1,373 60-count cartons
- Distribution pattern
- Product was distributed throughout the United States to various distributors who may have further distributed the product.
Timeline
- Recall initiated
- 2018-09-20
- FDA classified
- 2018-10-18
- Posted by FDA
- 2018-10-24
- Terminated
- 2019-11-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0082-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.