FDA recall D-0378-2021

Product

Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2021-04-26

Report date

2021-05-26

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-0378-2021