XZEN Platinum Recalled for Undeclared Sildenafil and Tadalafil
Schindele Enterprises is recalling XZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
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 is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.
Plain-English summary
Schindele Enterprises dba Midwest Wholesale is recalling 89 blister packs of XZEN Platinum, 750 mg, distributed by XZEN in Los Angeles, California. The product is identified by Lot 130520PL with an expiration date of 05/31/2017.
The recall was initiated because the dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. These ingredients are prescription drugs that were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected products were distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin. Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.
- Manufacturer
- Schindele Enterprises dba Midwest Wholesale
- Category
- Drug — Dietary Supplement
- Affected units
- 89
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 (1)
- Lot 130520PL Exp. 05/31/2017
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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