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Class III: unlikely to cause harmTerminated

Fresenius Kabi Fluphenazine Decanoate Injection Recall

Fluphenazine Decanoate Injection, USP

Fresenius Kabi USA, LLC · Lake Zurich, IL

Risk level
Class III
Reported by FDA
Apr 12, 2017
Recall ID
D-0647-2017
Check your lot numberHow we source this data

Summary

Fresenius Kabi recalled Fluphenazine Decanoate Injection starting Mar 16, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0647-2017 on Apr 12, 2017. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

Lot numbers, UPCs & expiration codes

Lot #: 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18

Where it was sold

Nationwide within the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0647-2017
Classification
Class III
Status
Terminated
Recall initiated
Mar 16, 2017
FDA report date
Apr 12, 2017
Quantity
118,224 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fresenius Kabi USA, LLC

Original FDA data

Every field from FDA enforcement report D-0647-2017, exactly as published.

Show all FDA fields
City
Lake Zurich
State
IL
Status
Terminated
Country
United States
Event ID
76728
Address
3 Corporate Dr
Code information
Lot #: 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18
Postal code
60047-8930
Report date
Apr 12, 2017
Product type
Drugs
Recall number
D-0647-2017
Classification
Class III
Recalling firm
Fresenius Kabi USA, LLC
Product quantity
118,224 vials
Termination date
Aug 28, 2018
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Distribution pattern
Nationwide within the US
Recall initiation date
Mar 16, 2017
Initial firm notification
Letter
Center classification date
Apr 5, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0647-2017, published Apr 12, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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