Food recall

Nexgen Pharma, Inc. recall: Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle...

Nexgen Pharma, Inc., of Colorado Springs, CO, recalled Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle.... The FDA's reason: “Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on April 15, 2013, and the FDA first listed it in its Enforcement Report of May 1, 2013. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

See FDA's words below

Status

Terminated

Closed September 6, 2013

The recall

Company
Nexgen Pharma, Inc. (Colorado Springs, CO)
Reason, in FDA's words
“Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient.”
Where it was sold
Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
64907

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1338-2013 Class III

    Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution information on the label. A general label template was provided with attachment B information. Product is sold in 50 and 100 ct bottles.

    Codes: Lot number 412567.

    Quantity: 4571 bottles.

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of May 1, 2013.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.