Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients
- Company Announcement Date:
- November 30, 2017
- FDA Publish Date:
- December 29, 2017
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason DescriptionUndeclared Active Pharmaceutical Ingredient
- Company Name:
- Nutra Labs Inc.
- Brand Name:
Brand Name(s)Bull, Chao Jimengnan
- Product Description:
Product DescriptionDietary Supplement
Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.
Use of products with undeclared sildenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. To date, Nutra Labs Inc. has not received any reports of adverse events related to this recall.
The products are marketed as dietary supplements for male sexual enhancement and are packaged as follows: Bull – 30 pills per tin, Chao Jimengnan – 4 pills per box.
The affected lots include the following expiration dates: Bull – 05-07-2019, Chao Jimengnan – 10/2017. The products can be identified by the word ‘Bull’ with an image of a Bull on a black tin in the case of ‘Bull’, and a square red box with ‘Chao Jimengnan Super Powerful Man Tablets’ printed on the front. Bull and Chao Jimengnan were distributed Nationwide via internet.
Nutra Labs Inc. is notifying its customers by e-mail and is arranging for return of all recalled products. Consumers or retailers that have Bull or Chao Jimengnan which is being recalled should stop using and return to PO Box 571, Ellenton FL 34222 ATTN: RETURNED GOODS for a refund.
Consumers with questions regarding this recall can contact Nutra Labs Inc. at 941-800-2883 or email@example.com M-F 9am-3pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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