Recalls / Class III
Class IIID-0511-2017
Product
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Affected lot / code info
- Lot # 34025762A, Exp 06/17
Why it was recalled
Failed Dissolution Specifications: low out of specification dissolution results found during 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
- 25,916 cartons
- Distribution pattern
- Nationwide in the United States and Puerto Rico
Timeline
- Recall initiated
- 2017-02-17
- FDA classified
- 2017-03-03
- Posted by FDA
- 2017-03-15
- Terminated
- 2018-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0511-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.