Why it was recalled
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Product description
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Lot numbers, UPCs & expiration codes
Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
Where it was sold
Nationwide in the U.S. and PR
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-0003-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- 32,543 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0003-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86379
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
- Postal code
- 07054-1120
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-0003-2021
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 32,543 cartons
- Termination date
- Aug 26, 2021
- Reason for recall
- Failed Stability Specifications: Below specification result for buprenorphine release rate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
- Distribution pattern
- Nationwide in the U.S. and PR
- Recall initiation date
- Sep 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 1, 2020