Why it was recalled
Discoloration and failed pH specifications
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0248-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2020
- FDA report date
- Feb 10, 2021
- Quantity
- 3094 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0248-2021, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87067
- Address
- 279 Princeton Hightstown Rd
- Code information
- 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
- Postal code
- 08520-1401
- Report date
- Feb 10, 2021
- Product type
- Drugs
- Recall number
- D-0248-2021
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 3094 cartons
- Termination date
- Sep 19, 2023
- Reason for recall
- Discoloration and failed pH specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2021