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.
Reported: March 15, 2017 Initiated: February 17, 2017 #D-0511-2017
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 25,916 cartons
- Distribution
- Nationwide in the United States and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 25,916 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 15, 2017. Severity: Low. Recall number: D-0511-2017.
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