# FDA recall D-0250-2021

> **Accord Healthcare, Inc.** · Class III · drug recall initiated 2021-01-28.

## Product

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA.  Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)

## Reason for recall

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0250-2021
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-28
- **Report date:** 2021-02-17
- **Termination date:** 2022-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2021

## Citation

> AI Analytics. FDA recall D-0250-2021. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/D-0250-2021. Source: US FDA. Licensed CC0.

---

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