Recalls / Class II
Class IID-0005-2015
Product
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.
- Brand name
- Amiodarone Hydrochloride
- Generic name
- Amiodarone Hydrochloride
- Active ingredient
- Amiodarone Hydrochloride
- Route
- Intravenous
- NDC
- 67457-153
- FDA application
- ANDA076217
- Affected lot / code info
- Lot #140502, Exp 10/31/2015
Why it was recalled
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Recalling firm
- Firm
- Mckesson
- Manufacturer
- Mylan Institutional LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 4345 Southpoint Blvd, Jacksonville, Florida 32216-6166
Distribution
- Quantity
- 10 vials
- Distribution pattern
- McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
Timeline
- Recall initiated
- 2014-09-12
- FDA classified
- 2014-10-03
- Posted by FDA
- 2014-10-15
- Terminated
- 2017-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.