HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

FDA recall notice · announced November 19, 2014 · Fresenius Kabi

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

Reason for recall

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Quantity: 216,517 vials
Status: Terminated
Products in this recall event:
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 (D-0247-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.