Drug recall D-0003-2021
Product
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.
Reason for recall
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Lots and codes
Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Quantity
- 32,543 cartons
- Distribution
- Nationwide in the U.S. and PR
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 4, 2020
- Terminated
- August 26, 2021
Related products
- Buprenorphine – drug information
- NDC 0093-3658 Buprenorphine · Buprenorphine 15 ug/h · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3659 Buprenorphine · Buprenorphine 20 ug/h · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3239 Buprenorphine · Buprenorphine 7.5 ug/h · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3656 Buprenorphine · Buprenorphine 5 ug/h · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3657 Buprenorphine · Buprenorphine 10 ug/h · Teva Pharmaceuticals USA, Inc.