Recalls / Class II
Class IID-0381-2019
Product
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454
- Affected lot / code info
- Lot #: a) 49O005, 49O006, 49O007, 49O010, Exp 02/2019; b) 49O005, 49O009, 49O010, Exp 02/2019
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 181,456 bottles
- Distribution pattern
- U.S.A. nationwide
Timeline
- Recall initiated
- 2018-12-19
- FDA classified
- 2019-01-16
- Posted by FDA
- 2019-01-23
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0381-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.