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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61802

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 01, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ben Venue Laboratories Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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 8.

D-1376-2012
Recall number
D-1376-2012
Initiated
May 01, 2012
Classification
Class II
Status
Terminated
Quantity
11,161 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Code information

Lot #1856177, Exp 06/30/13

Distribution pattern

Nationwide and Puerto Rico.

drug · product 2 of 2

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 55390-160-10; UPC 3 55390-160-10 1.

D-1377-2012
Recall number
D-1377-2012
Initiated
May 01, 2012
Classification
Class II
Status
Terminated
Quantity
6,515 packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Code information

Lot # 2006500, Exp 08/31/12

Distribution pattern

Nationwide and Puerto Rico.

Field note

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