Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Product description
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Lot numbers, UPCs & expiration codes
34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
Where it was sold
Nationwide 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-1325-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 7, 2014
- FDA report date
- May 28, 2014
- Quantity
- 53,452 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1325-2014, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68069
- Address
- 1090 Horsham Rd
- Code information
- 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
- Postal code
- 19454-1505
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1325-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 53,452 bottles
- Termination date
- Nov 20, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 7, 2014
- Initial firm notification
- Letter
- Center classification date
- May 16, 2014