FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL...

  • U.S. Food and Drug Administration
  • June 20, 2012
  • ID: D-1377-2012

Drug Enforcement Report Details

Recall NumberD-1377-2012
Recalling FirmBen Venue Laboratories Inc
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternNationwide and Puerto Rico.
StatusTerminated
Product Description

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.

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


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.