Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose
Recalled August 25, 2021 · FDA recall D-0732-2021 · Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
16,226 vials
Sold at
Product was distributed Nationwide, including Puerto Rico.
Description
Lack of Assurance of Sterility
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →