Agency classClass IOur severity:Critical FDA (Drugs)·D-335-2013·Announced 2013-05-22

BLUE Diamond Platinum Capsules Recalled for Undeclared Active Ingredients

Performance Plus Marketing is recalling BLUE Diamond Platinum Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

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

Performance Plus Marketing, Inc. is recalling BLUE Diamond Platinum Capsules, 1000 mg, in 1, 5, and 10 count blister packs. The product was distributed nationwide by DH Distribution in Los Angeles, CA. Specific lot numbers and expiration dates are listed in the recall notice.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules may contain undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients. Consequently, the product is considered an unapproved drug.

Consumers who have purchased these products should stop using them and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product: BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Unapproved Drug
Hazard: undeclared-ingredients
unapproved-drug
Affected units: 1,000

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 (7)

(1 count)Lot# 01MNU0912
Exp: 08/15
(5 count) Lot# 05BD0712
Exp: 07/15 and 121781
Exp 01/14
(10 count) Lot # 05BD0712
Exp: 07/15

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.

See all →

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Same hazard · undeclared ingredients