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Class III: unlikely to cause harmTerminated

Nexgen Pharma Free Form Amino Acids L-Arginine 7 Recall

Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes…

Nexgen Pharma, Inc. · Colorado Springs, CO

Risk level
Class III
Reported by FDA
May 1, 2013
Recall ID
F-1338-2013
Check your lot numberHow we source this data

Summary

Nexgen Pharma recalled Free Form Amino Acids L-Arginine 7 starting Apr 15, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-1338-2013 on May 1, 2013. 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. Status: Terminated.

Why it 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.

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.

Lot numbers, UPCs & expiration codes

Lot number 412567.

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1338-2013
Classification
Class III
Status
Terminated
Recall initiated
Apr 15, 2013
FDA report date
May 1, 2013
Quantity
4571 bottles.
Recall type
Voluntary: Firm initiated
Recalling firm
Nexgen Pharma, Inc.

Original FDA data

Every field from FDA enforcement report F-1338-2013, exactly as published.

Show all FDA fields
City
Colorado Springs
State
CO
Status
Terminated
Country
United States
Event ID
64907
Address
1835 E Cheyenne Rd
Code information
Lot number 412567.
Postal code
80905-2868
Report date
May 1, 2013
Product type
Food
Recall number
F-1338-2013
Classification
Class III
Recalling firm
Nexgen Pharma, Inc.
Product quantity
4571 bottles.
Termination date
Sep 6, 2013
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.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Distributed to large and small retailers located nationwide as well as two foreign locations (Canada and Netherlands).
Recall initiation date
Apr 15, 2013
Initial firm notification
Letter
Center classification date
Apr 19, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1338-2013, published May 1, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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