# FDA recall D-1225-2014

> **Agila Specialties Private Ltd.** · Class II · drug recall initiated 2014-02-14.

## Product

etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY  10017.

## Reason for recall

Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1225-2014
- **Recalling firm:** Agila Specialties Private Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-02-14
- **Report date:** 2014-04-16
- **Termination date:** 2015-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bangalore, Karnataka, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1225-2014

## Citation

> AI Analytics. FDA recall D-1225-2014. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1225-2014. Source: US FDA. Licensed CC0.

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