FDAFDA · Food and drugs·Recall number D-0003-2021
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.
Published October 7, 2020 · Recall initiated: September 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Below specification result for buprenorphine release rate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPRENORPHINE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the U.S. and PR
- Lot
- Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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