Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
Reported: December 4, 2019 Initiated: November 11, 2019 #D-0521-2020
Product Description
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09
Reason for Recall
Crystallization: Presence of visible particulate matter.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 29,830 vials
- Distribution
- Distributed Nationwide in the US
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09. Recalled by AuroMedics Pharma LLC. Units affected: 29,830 vials.
Why was this product recalled? ▼
Crystallization: Presence of visible particulate matter.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 4, 2019. Severity: Low. Recall number: D-0521-2020.
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