ExtenZe 600 mg Recalled for Undeclared Sildenafil and Tadalafil
Schindele Enterprises is recalling ExtenZe 600 mg tablets because they contain undeclared sildenafil or tadalafil, which were marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Schindele Enterprises dba Midwest Wholesale is recalling 57 boxes of ExtenZe 600 mg, 30 tablet boxes. The product was manufactured for Biotab Nutraceuticals, Inc., in Pasadena, CA. The specific lot number is 0512058, with an expiration date of 05/16.
The recall was initiated because the dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. The source text notes that these products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected product was distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin. Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.
- Manufacturer
- Schindele Enterprises dba Midwest Wholesale
- Category
- Drug — Dietary Supplement
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 0512058
- Exp. 05/16
Distribution
Part of a larger recall action
This product is one of 7 recalled by Schindele Enterprises dba Midwest Wholesale under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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