FDA-Drug2016-04-20Class III
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Fresenius Kabi USA, LLC
Hazard
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Sold states
Nationwide and Puerto Rico
Affected count
48,210 units
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0818-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief