The Recall Desk

FDA (Drugs) recall action 61802

Ben Venue Laboratories Inc recalled 2 products on 2012-06-20

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-06-20
Critical
0
Units
17,676

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··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.

    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 55390-160-10
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··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.

    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 8
    Category
    Distribution
    1 state