Recalls / Class III
Class IIID-0647-2017
Product
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
- Affected lot / code info
- Lot #: 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18
Why it was recalled
Subpotent Drug
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
- 118,224 vials
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-03-16
- FDA classified
- 2017-04-05
- Posted by FDA
- 2017-04-12
- Terminated
- 2018-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0647-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.