HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
Reported: November 19, 2014 Initiated: April 14, 2014 #D-0247-2015
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA LLC
- Units Affected
- 216,517 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01. Recalled by Fresenius Kabi USA LLC. Units affected: 216,517 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 19, 2014. Severity: Low. Recall number: D-0247-2015.
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