Recalls / Class II
Class IID-0208-2018
Product
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
- Affected lot / code info
- Lot # 30229439A, Exp 12/17
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was 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
- 4,969 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-12-14
- FDA classified
- 2018-01-08
- Posted by FDA
- 2018-01-17
- Terminated
- 2018-10-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0208-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.