Recalls / Class III
Class IIID-0818-2016
Product
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, 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 #: 6111080, Exp. 01/2017
Why it was recalled
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 48,210 units
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-07
- FDA classified
- 2016-04-11
- Posted by FDA
- 2016-04-20
- Terminated
- 2016-11-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0818-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.