Why it was recalled
Crystallization: Presence of visible particulate matter.
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
Lot numbers, UPCs & expiration codes
Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
Where it was sold
Distributed Nationwide in the US
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-0521-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 11, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 29,830 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0521-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84240
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020
- Postal code
- 08520-1401
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0521-2020
- Classification
- Class III
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 29,830 vials
- Termination date
- Apr 1, 2021
- Reason for recall
- Crystallization: Presence of visible particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Nov 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2019