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
Product description
libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
Lot numbers, UPCs & expiration codes
1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-332-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2012
- FDA report date
- May 22, 2013
- Quantity
- 610,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Performance Plus Marketing, Inc.
Original FDA data
Every field from FDA enforcement report D-332-2013, exactly as published.
Show all FDA fields
- City
- Commerce
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63916
- Address
- 5560 E 61st St
- Code information
- 1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16.
- Postal code
- 90040-3406
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-332-2013
- Classification
- Class I
- Recalling firm
- Performance Plus Marketing, Inc.
- Product quantity
- 610,000 capsules
- Termination date
- Nov 14, 2013
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 17, 2012
- Initial firm notification
- Telephone
- Center classification date
- May 16, 2013