Why it was recalled
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Product description
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Lot numbers, UPCs & expiration codes
Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
Where it was sold
Nationwide in the USA
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-0983-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 29, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- 25264 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0983-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77725
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
- Postal code
- 19454-1505
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0983-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 25264 bottles
- Termination date
- Apr 26, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 29, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2017