Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged...
FDA Recall #D-0515-2016 — Class II — November 11, 2015
Product Description
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
Reason for Recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Recalling Firm
RemedyRepack Inc. — Indiana, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1625 Vials
Distribution
Nationwide
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated