Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

FDA recall notice · announced April 20, 2016 · 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, Lake Zurich, IL 60047, NDC 63323-469-01.

Reason for recall

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 6111080, Exp. 01/2017
Quantity: 48,210 units
Status: Terminated
Products in this recall event:
- Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. (D-0818-2016)

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