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Recall Observatory FDA recall evidence

Food product

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.

F-1338-2013

April 15, 2013

Class III

Product summary

Firm
Nexgen Pharma, Inc.
Event
Event 64907
Status
Terminated
Classification
Class III
Quantity
4571 bottles.
Official record key
food-enforcement:F-1338-2013

Official wording

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.

Code information: Lot number 412567.

Distribution pattern: Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    subpotency