Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0647-2017·Announced 2017-04-12

Fresenius Kabi Recalls Subpotent Fluphenazine Decanoate Injection Vials

Fresenius Kabi USA is recalling 118,224 vials of Fluphenazine Decanoate Injection because the drug was found to be subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. While subpotent drugs are a quality issue, the agency's classification places this in the lower severity range, typically corresponding to a score of 1 or 2. Given the potential for therapeutic failure, a score of 2 is appropriate.

Plain-English summary

Fresenius Kabi USA, LLC is voluntarily recalling 118,224 vials of Fluphenazine Decanoate Injection, USP. The product is a prescription-only medication packaged in 5mL vials with a concentration of 25 mg/mL. The recall was initiated on March 16, 2017, and the affected lots were distributed nationwide within the United States.

The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the United States Pharmacopeia (USP). The affected lots include 6111141 (Exp. 07/17), 6111222 (Exp. 08/17), 6112346 (Exp. 01/18), and 6112725 (Exp. 03/18).

The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall status is currently terminated as of August 28, 2018. Patients and healthcare providers should check their inventory for these specific lot numbers and contact the manufacturer or their pharmacy for further instructions.

The recalled product

Product: Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injection
Hazard: subpotent-drug
Affected units: 118,224

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Fresenius Kabi USA, LLC

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