FDA recall D-0248-2021

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-30

Report date

2021-02-10

Termination date

2023-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0248-2021