LOW RISK Terminated F-1338-2013

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.

Recalled by Nexgen Pharma, Inc.

Classification

Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.

Reason for Recall

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.

Product Details

Product Quantity
4571 bottles.
Product Type
Food
Code Info
Lot number 412567.
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).
Company Location
Colorado Springs, CO, 80905-2868

Timeline

Report Date
05/01/2013
Recall Initiated
04/15/2013
Classification Date
04/19/2013
Termination Date
09/06/2013

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 29, 2026

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