Agency classClass IOur severity:Critical FDA (Drugs)·D-0674-2016·Announced 2016-02-24

Medisca Recalls L-Citrulline API Due to Labeling Error

Medisca Inc is recalling L-Citrulline API bottles because FDA testing found the product contained N-acetyl-leucine instead of the labeled ingredient.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Medisca Inc is recalling specific bottles of L-Citrulline API (Active Pharmaceutical Ingredient) due to a labeling error. The affected products are white crystals or crystalline powder packaged in 25 g, 100 g, 500 g, and 1 kg plastic bottles. The recall covers specific lot numbers with an expiration date of 10/31/2014.

The FDA tested samples of the API labeled as L-Citrulline and found that no L-Citrulline was present. Instead, the samples contained N-acetyl-leucine. This constitutes a label mix-up where the actual chemical content did not match the product label.

The affected products were distributed nationwide and in Australia. The products are intended for use in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations. Consumers and healthcare professionals should stop using the affected lots and contact Medisca Inc for instructions on return or disposal.

The recalled product

Product: CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by…
Manufacturer: Medisca Inc
Category: Drug — Active Pharmaceutical Ingredient (API)
Hazard: mis-labeling
wrong-ingredient

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 (9)

Lot #s: 95482/A
95482/B
95482/C
95482/D
96453/A
96453/B
96453/C
and 96453/D
Exp. 10/31/2014

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medisca Inc

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