The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1376-2012·Announced 2012-06-20

Ben Venue Recalls Midazolam HCl Injection Due to Potential Low Fill Volume

Ben Venue Laboratories is recalling Midazolam HCl Injection vials because some may have low fill volume. The recall covers 11,161 packs distributed nationwide and in Puerto Rico.

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 potential dosing error (low fill volume) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Ben Venue Laboratories, Inc. is recalling Midazolam HCl Injection, 5 mg/mL, 1 mL single-use vials. The recall involves 11,161 packs, each containing 10 vials. The products are identified by Lot #1856177 and have an expiration date of 06/30/13.

The recall was initiated because there is a potential that vials with low fill volume were released into distribution. This means some vials may not contain the full labeled amount of medication.

The affected products were distributed nationwide and in Puerto Rico. Healthcare providers and pharmacies should stop using the recalled vials and contact the manufacturer for instructions on how to return them.

The recalled product

Product
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01…
Manufacturer
Ben Venue Laboratories Inc
Category
Drug — Injection
Hazard
Affected units
11,161

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 (2)

  • Lot #1856177
  • Exp 06/30/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Ben Venue Laboratories 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.

See all 2 products in this recall →

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