CLASS III Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Fluphenazine Decanoate Injection recalled by Fresenius Kabi USA
Fresenius Kabi USA is recalling Fluphenazine Decanoate Injection, USP, distributed nationwide in the US. The recall was initiated on 16 Mar 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0647-2017
- FDA event ID
- 76728
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Mar 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Mar 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +20 days |
| 12 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18
Where was it sold?
Nationwide within the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Fluphenazine Decanoate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine Decanoate Injection USP 125mg/ Multiple Dose Vial) recalled | AuroMedics Pharma | Other | Nationwide |