Drug product
Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16
D-0514-2016
Product summary
- Event
- Event 72699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Vial
- Official record key
drug-enforcement:D-0514-2016
Official wording
Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Code information: LOT # B0105052-100715, Exp 07/01/2017
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect