Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Reported: April 20, 2016 Initiated: April 7, 2016 #D-0818-2016
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 48,210 units
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product 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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 48,210 units.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 20, 2016. Severity: Low. Recall number: D-0818-2016.
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