PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 20, 2012 Initiated: May 1, 2012 #D-1377-2012

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.

Details

Units Affected
6,515 packs
Distribution
Nationwide and Puerto Rico.
Location
Bedford, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ben Venue Laboratories Inc. Units affected: 6,515 packs.
Why was this product recalled?
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1377-2012.