Recalls / Class I
Class ID-333-2013
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
libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922.
- Affected lot / code info
- 1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14.
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
- 686,000 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-333-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.