FDA recall D-0744-2021

Product

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed Nationwide, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-07-29

Report date

2021-08-25

Termination date

2024-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0744-2021