Drug & medication recalls

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

Recall date
April 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0818-2016
FDA classification
Class III
Brand / firm
Fresenius Kabi USA, LLC
Sold / distributed
Nationwide and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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