FDA recall D-1377-2012

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; 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.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-05-01

Report date

2012-06-20

Termination date

2013-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1377-2012