Z-ROCK Male Supplement Recalled for Unapproved Sildenafil Content
Coral Rock Man, Inc. is recalling Z-ROCK All Natural Male Supplement because testing revealed the presence of Sildenafil and its analogs, which were not approved in the product.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Coral Rock Man, Inc. is voluntarily recalling Z-ROCK All Natural Male Supplement, a 1-capsule blister pack distributed by Zrock USA. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory testing confirmed that the supplement contains Sildenafil and analogs of Sildenafil, which are not approved ingredients for this product.
The product was distributed to three distributors and wholesalers, who then sold it nationwide through internet and retail channels. The recall covers all lots and codes of the product. The manufacturer is Coral Rock Man, Inc., and the distributor is Zrock USA, located in Pompano Beach, Florida.
Consumers who have purchased Z-ROCK All Natural Male Supplement should stop using the product and contact the distributor or retailer for a refund or further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The recalled product
- Product
- Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
- Manufacturer
- Coral Rock Man, Inc.
- Category
- Drug — Dietary Supplement
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)
- All Lots All codes.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Coral Rock Man, Inc. 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.
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