RemedyRepack Recalls Lorazepam Injections Due to Incorrect Storage Instructions
RemedyRepack Inc. is recalling 1,625 vials of Lorazepam 2 mg/mL injection because the product labels contain incorrect storage instructions.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect storage instructions) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
RemedyRepack Inc. is voluntarily recalling 1,625 vials of Lorazepam 2 mg/mL Injection. The product was originally manufactured by West-Ward Pharma and repackaged by RemedyRepack Inc. The recall is being conducted because the product labels contain incorrect storage instructions.
The affected product is identified by NDC 61786-0316-01. Specific lot numbers and expiration dates are listed in the recall documentation. The products were distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be returned to the supplier or disposed of according to local regulations. No specific health risks or adverse events are reported in the source text.
The recalled product
- 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
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,625
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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