The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1377-2012·Announced 2012-06-20

Ben Venue Recalls Octreotide Acetate Injection Due to Potential Low Fill Volume

Ben Venue Laboratories is recalling Octreotide Acetate Injection vials because some may have low fill volume. The recall covers 6,515 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a potential low fill volume, which is a quality control issue rather than a contamination or serious injury risk.

Plain-English summary

Ben Venue Laboratories, Inc. is recalling Octreotide Acetate Injection, 50 mcg/mL, 1 mL single dose vials. The recall is being conducted because there is potential that vials with low fill volume were released into distribution.

The affected product is packaged in 10 x 1 mL single dose vials per pack. The specific lot number is 2006500, with an expiration date of 08/31/12. The NDC is 55390-160-10. A total of 6,515 packs were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the supplier or disposed of according to local regulations. Patients should contact their healthcare provider for alternative treatment options if they have this specific product.

The recalled product

Product
Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC…
Manufacturer
Ben Venue Laboratories Inc
Category
Drug — Injection
Hazard
Affected units
6,515

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 # 2006500
  • Exp 08/31/12

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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