Recalls / Class III
Class IIID-0247-2015
Product
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Active ingredient
- Haloperidol Decanoate
- Route
- Intramuscular
- NDCs
- 63323-469, 63323-471
- FDA application
- ANDA074893
- Affected lot / code info
- Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
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.
Recalling firm
- Firm
- Fresenius Kabi USA LLC
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2020 N Ruby St, Melrose Park, Illinois 60160-1112
Distribution
- Quantity
- 216,517 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-04-14
- FDA classified
- 2014-11-13
- Posted by FDA
- 2014-11-19
- Terminated
- 2016-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0247-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.