Recalls / Class I
Class ID-335-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- (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
Why it was recalled
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Recalling firm
- Firm
- Performance Plus Marketing, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 5560 E 61st St, Commerce, California 90040-3406
Distribution
- Quantity
- 1,000 capsules.
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-17
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2013-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-335-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.