Risedronate Sodium Delayed-release Tablets recall: Failed Dissolution
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.
Why was Risedronate Sodium Delayed-release Tablets recalled?
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 34025762A, Exp 06/17
- 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.
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 25,916 cartons
- Distribution
- Nationwide in the United States and Puerto Rico
- Recall date
- March 15, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)