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Recall Observatory FDA recall evidence

Drug 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.

D-0005-2015

September 12, 2014

Class II

Product summary

Firm
Mckesson
Event
Event 69346
Status
Terminated
Classification
Class II
Quantity
10 vials
Official record key
drug-enforcement:D-0005-2015

Official wording

Reason: 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.

Code information: Lot #140502, Exp 10/31/2015

Distribution pattern: McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.