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
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
Lot numbers, UPCs & expiration codes
(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
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-335-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2012
- FDA report date
- May 22, 2013
- Quantity
- 1,000 capsules.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Performance Plus Marketing, Inc.
Original FDA data
Every field from FDA enforcement report D-335-2013, 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)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15
- Postal code
- 90040-3406
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-335-2013
- Classification
- Class I
- Recalling firm
- Performance Plus Marketing, Inc.
- Product quantity
- 1,000 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
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 17, 2012
- Initial firm notification
- Telephone
- Center classification date
- May 16, 2013