FDA Drug recall D-0003-2021
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery…
- FDA Drug
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery… by Teva Pharmaceuticals Usa, citing failed Stability Specifications: Below specification result for buprenorphine release rate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0003-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-04 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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.
Reason
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Identifiers
| ndc | 0093-3656-40 |
|---|---|
| ndc | 0093-3239-40 |
| ndc | 0093-3657-40 |
| ndc | 0093-3658-40 |
| ndc | 0093-3659-40 |
| ndc | 0093-3656-21 |
| code_info | Lot # 190017, exp. 02/2021; 190161, exp. 08/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.