FDAFDA · Food and drugs·Recall number D-0511-2017
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.
Published March 15, 2017 · Recall initiated: February 17, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the United States and Puerto Rico
- Lot
- Lot # 34025762A, Exp 06/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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