Acetaminophen Injection 1 — Class II drug recall D-0248-2021
Terminated recall by AuroMedics Pharma LLC, reported 2021-02-10, distributed nationwide. Discoloration and failed pH specifications
| Recall number | D-0248-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2020-12-30 |
| Classified | 2021-02-04 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-09-19 |
| Distributed | Nationwide (US) |
| Quantity | 3,094 cartons |
| NDC | 55150-0307, 55150-0307-01, 55150-0307-24 |
| Model numbers | 200002, 200004, 200005, 200008, 200009, 200013, 200014, 200015, 200016, 200017, 200018 |
| Expiration dates | 2022-09, 2022-10 |
Product
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01
Reason for recall
Discoloration and failed pH specifications
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-0248-2021. 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.