Reported Nov 19, 2014 · Terminated
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC…
Fresenius Kabi USA LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA LLC · 2020 N Ruby St · Melrose Park, IL · 60160-1112
Is this the product you have?
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- Lot codes and dates
Lot 6105149Exp.05/146105696Exp. 07/146105836Exp. 08/14Lot 6106516Exp. 12/14Lot 6106837Exp. 02/15
- Amount recalled
- 216,517 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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