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
Reported: February 10, 2021 Initiated: December 30, 2020 #D-0248-2021
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
Reason for Recall
Discoloration and failed pH specifications
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 3094 cartons
- Distribution
- Nationwide
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AuroMedics Pharma LLC. Units affected: 3094 cartons.
Why was this product recalled? ▼
Discoloration and failed pH specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 10, 2021. Severity: Moderate. Recall number: D-0248-2021.
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