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.
Reported: October 7, 2020 Initiated: September 4, 2020 #D-0003-2021
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 32,543 cartons
- Distribution
- Nationwide in the U.S. and PR
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 32,543 cartons.
Why was this product recalled? ▼
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-0003-2021.
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