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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