Recalls / Class III
Class IIID-0521-2020
Product
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
- Brand name
- Amiodarone Hydrochloride
- Generic name
- Amiodarone Hydrochloride
- Active ingredient
- Amiodarone Hydrochloride
- Route
- Intravenous
- NDCs
- 55150-180, 55150-181, 55150-182
- FDA application
- ANDA204550
- Affected lot / code info
- Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
Why it was recalled
Crystallization: Presence of visible particulate matter.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 29,830 vials
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2019-11-11
- FDA classified
- 2019-11-22
- Posted by FDA
- 2019-12-04
- Terminated
- 2021-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0521-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.