FDA recall D-0732-2021

Product

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

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-0732-2021