Why it was recalled
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
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.
Lot numbers, UPCs & expiration codes
Lot # 34025762A, Exp 06/17
Where it was sold
Nationwide in the United States and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0511-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2017
- FDA report date
- Mar 15, 2017
- Quantity
- 25,916 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0511-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 76513
- Address
- 1090 Horsham Rd
- Code information
- Lot # 34025762A, Exp 06/17
- Postal code
- 19454-1505
- Report date
- Mar 15, 2017
- Product type
- Drugs
- Recall number
- D-0511-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 25,916 cartons
- Termination date
- Feb 5, 2018
- Reason for recall
- Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the United States and Puerto Rico
- Recall initiation date
- Feb 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2017