Amiodarone Hydrochloride Injection — Class III drug recall D-0522-2020
Terminated recall by AuroMedics Pharma LLC, reported 2019-12-04, distributed nationwide. Crystallization: Presence of visible particulate matter.
| Recall number | D-0522-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2019-11-11 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 138,720 vials |
| Reason classes | specification failure |
| NDC | 55150-0180, 55150-0180-03, 55150-0181, 55150-0181-09, 55150-0182, 55150-0182-18 |
| Lot numbers | CAH180013, CAH180014 |
| Expiration dates | 2020-07-20 |
Product
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18
Reason for recall
Crystallization: Presence of visible particulate matter.
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-0522-2020. 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.