BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed...

FDA Drug Recall #D-335-2013 — Class I — December 17, 2012

Recall Summary

Recall Number D-335-2013
Classification Class I — Serious risk
Date Initiated December 17, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Performance Plus Marketing, Inc.
Location Commerce, CA
Product Type Drugs
Quantity 1,000 capsules.

Product Description

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

Reason for Recall

Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs

Distribution Pattern

Nationwide

Lot / Code Information

(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

Other Recalls from Performance Plus Marketing, Inc.

Recall # Classification Product Date
D-334-2013 Class I BLUE Diamond Pill, supplied in 1, 5 and 10 coun... Dec 17, 2012
D-336-2013 Class I Mojo nights Capsules, Male Sexual Enhancer, sup... Dec 17, 2012
D-338-2013 Class I CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER... Dec 17, 2012
D-337-2013 Class I Mojo nights SUPREME Capsules, 1000 mg, Male Sex... Dec 17, 2012
D-332-2013 Class I libigrow capsules, PERFORMANCE ENHANCER, suppli... Dec 17, 2012

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.