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 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.
Lot numbers, UPCs & expiration codes
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.
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-333-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2012
- FDA report date
- May 22, 2013
- Quantity
- 686,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Performance Plus Marketing, Inc.
Original FDA data
Every field from FDA enforcement report D-333-2013, 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# 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.
- Postal code
- 90040-3406
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-333-2013
- Classification
- Class I
- Recalling firm
- Performance Plus Marketing, Inc.
- Product quantity
- 686,000 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 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 17, 2012
- Initial firm notification
- Telephone
- Center classification date
- May 16, 2013