Class II
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- September 4, 2020
- Posted
- October 7, 2020
- Recall Number
- D-0003-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32,543 cartons
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Distribution
Nationwide in the U.S. and PR
Lot / Code Info
Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
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