Recall record at a glance
| Official record | F-1338-2013 |
|---|---|
| Category | Food Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Nexgen Pharma, Inc. |
| Report date | May 1, 2013 |
| Recall initiation date | Apr 15, 2013 |
| Quantity | 4571 bottles. |
| Location | Colorado Springs, CO, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.