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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #140502, Exp 10/31/2015
Where it was sold
McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
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-0005-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 12, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 10 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson
Original FDA data
Every field from FDA enforcement report D-0005-2015, exactly as published.
Show all FDA fields
- City
- Jacksonville
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69346
- Address
- 4345 Southpoint Blvd
- Code information
- Lot #140502, Exp 10/31/2015
- Postal code
- 32216-6166
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0005-2015
- Classification
- Class II
- Recalling firm
- Mckesson
- Product quantity
- 10 vials
- Termination date
- Apr 17, 2017
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.
- Recall initiation date
- Sep 12, 2014
- Initial firm notification
- Telephone
- Center classification date
- Oct 3, 2014