Class III
Terminated
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.
This recall has been terminated (originally issued March 15, 2017).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 17, 2017
- Posted
- March 15, 2017
- Recall Number
- D-0511-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25,916 cartons
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Distribution
Nationwide in the United States and Puerto Rico
Lot / Code Info
Lot # 34025762A, Exp 06/17
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