# FDA recall D-0466-2023

> **AVEVA Drug Delivery Systems, Inc.** · Class III · drug recall initiated 2023-02-15.

## Product

Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC  60505-7079-05

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0466-2023
- **Recalling firm:** AVEVA Drug Delivery Systems, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-15
- **Report date:** 2023-03-22
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miramar, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0466-2023

## Citation

> AI Analytics. FDA recall D-0466-2023. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0466-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*