FDA-Drug2021-08-25Class II
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.
Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility
Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
16,226 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2021Don't want to check this manually?
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