Class III
Terminated
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
- Company
- Auromedics Pharma Llc
- Recall Initiated
- November 11, 2019
- Posted
- December 4, 2019
- Recall Number
- D-0521-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 29,830 vials
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
Crystallization: Presence of visible particulate matter.
Distribution
Distributed Nationwide in the US
Lot / Code Info
Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
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