D-0003-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- September 4, 2020
- Termination Date
- August 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,543 cartons
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.
Reason for Recall
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Distribution Pattern
Nationwide in the U.S. and PR
Code Information
Lot # 190017, exp. 02/2021; 190161, exp. 08/2021