Agency classClass IOur severity:Critical FDA (Drugs)·D-334-2013·Announced 2013-05-22

FDA Recalls Blue Diamond Pill for Undeclared Sildenafil and Tadalafil

Performance Plus Marketing, Inc. is recalling Blue Diamond Pill male sexual enhancement products because they may contain undeclared sildenafil, tadalafil, and analogues.

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 corresponds to a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.

Plain-English summary

Performance Plus Marketing, Inc. is recalling Blue Diamond Pill, a male sexual enhancement product, because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product is supplied in 1, 5, and 10 count blister packs and distributed by DH Distribution in Los Angeles, California.

The recall is due to the potential presence of undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients, which makes the product an unapproved drug. Approximately 213,000 capsules were distributed nationwide. Affected lots include Lot# 01M0412 (Exp: 04/15), Lot#91782 (Exp: 01/14), Lot# 05M0412 (Exp: 04/15), and Lot# 10M0412 (Exp: 04/15).

Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product: BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Sexual Enhancement
Hazard: undeclared-ingredients
unapproved-drug
Affected units: 213,000

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 (6)

1 count blister: Lot# 01M0412
Exp: 04/15
and Lot#91782
Exp: 01/14. 5 count blister: Lot# 05M0412
10 count blister: Lot# 10M0412
Exp: 04/15.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Performance Plus Marketing, 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.

See all 7 products in this recall →

Same manufacturer · Performance Plus Marketing, Inc.

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