# FDA recall D-0003-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-09-04.

## 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 for recall

Failed Stability Specifications: Below specification result for buprenorphine release rate.

## Distribution

Nationwide in the U.S. and PR

## Key facts

- **Recall number:** D-0003-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-04
- **Report date:** 2020-10-07
- **Termination date:** 2021-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2021

## Citation

> AI Analytics. FDA recall D-0003-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/D-0003-2021. Source: US FDA. Licensed CC0.

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