Recalls / Class II
Class IID-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
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Intravenous
- NDC
- 55150-307
- FDA application
- ANDA210969
- Affected lot / code info
- CAT200002 exp 9/2022; CAT200004 exp 9/2022; CAT200005 exp 9/2022; CAT200008 exp 9/2022; CAT200009 exp 9/2022; CAT200013 exp 10/2022; CAT200014 exp 10/2022; CAT200015 exp 10/2022; CAT200016 exp 10/2022; CAT200017 exp 10/2022; CAT200018 exp 10/2022
Why it was recalled
Discoloration and failed pH specifications
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 3094 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-12-30
- FDA classified
- 2021-02-04
- Posted by FDA
- 2021-02-10
- Terminated
- 2023-09-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0248-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.