FDA-Drug2021-02-10Class II

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

AuroMedics Pharma LLC
Hazard

Discoloration and failed pH specifications

Sold states
Nationwide
Affected count
3094 cartons
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief