Drug product
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
D-0668-2017
Product summary
- Event
- Event 76863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98 vials
- Official record key
drug-enforcement:D-0668-2017
Official wording
Reason: Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Code information: Lot #s: 6114311, 6114717, Exp 05/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.