Drug product
Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01
D-0515-2016
Product summary
- Event
- Event 72699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1625 Vials
- Official record key
drug-enforcement:D-0515-2016
Official wording
Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Code information: LOT#: B0085124-051915, B0086919-052815, Exp 12/01/2016; B0089280-061215, B0090023-061915, B0089996-061915, B0091581-070715, B0091564-070715, B0091515-070715, Exp 01/01/2017; B0094980-080415, B0094965-080415, B0097515-082415, B0100639-091415, B0100611-091415, Exp 03/01/2017; B0100933-091515, B0107165-101915, B0107118-101915, Exp 06/01/2017.
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect