FDAClass IIIApril 12, 2017

Fluphenazine Decanoate Injection recall: Subpotent

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

Why was Fluphenazine Decanoate Injection recalled?

Subpotent Drug

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Recalling firm
Fresenius Kabi USA, LLC
Quantity
118,224 vials
Distribution
Nationwide within the US
Recall date
April 12, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls