Recalls / Class II
Class IID-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.
- Brand name
- Buprenorphine
- Generic name
- Buprenorphine
- Active ingredient
- Buprenorphine
- Route
- Transdermal
- NDCs
- 0093-3239, 0093-3656, 0093-3657, 0093-3658, 0093-3659
- FDA application
- ANDA204937
- Affected lot / code info
- Lot # 190017, exp. 02/2021; 190161, exp. 08/2021
Why it was recalled
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 32,543 cartons
- Distribution pattern
- Nationwide in the U.S. and PR
Timeline
- Recall initiated
- 2020-09-04
- FDA classified
- 2020-10-01
- Posted by FDA
- 2020-10-07
- Terminated
- 2021-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0003-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.