etomidate injection — Class II drug recall D-1225-2014
Terminated recall by Agila Specialties Private Ltd., reported 2014-04-16, distributed nationwide. Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the pot
| Recall number | D-1225-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agila Specialties Private Ltd., Bangalore, Karnataka, N/A, India |
| Recall initiated | 2014-02-14 |
| Classified | 2014-04-08 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2015-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 7,919 cartons |
| Reason classes | specification failure |
| NDC | 00069-0006-01, 00069-0006-02, 00069-0006-03, 00069-0006-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1225-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.