Recalls, Investments, Verifications: Health And Wellness Industry News

Supplements spiked with ED drugs recalled; Agritek Holdings purchases nutrition and supplement marketer Performance Nutrition Center; more dietary supplement recalls and other news in brief.

3 ED drugs in one recalled supplement

FDA received adverse event reports on one of two products marketed as dietary supplements that were recalled on Sept. 20 after being found spiked with drug ingredients indicated for erectile dysfunction. Gadget Island Inc. recalled five male sexual enhancement products found containing undeclared pharmaceutical ingredients sildenafil and tadalafil, which are approved by FDA for ED drugs, and desmethyl carbodenafil, a chemical structurally similar to sildenafil that is not an approved drug. The products are branded Rhino 7, Platinum 5000, Papa Zen 3000, Fifty Shades 6000 and Grande X 5800. The Newark, Calif, firm, which does business as Gear Isle, says it has received no AERs from consumers about the product but it is notifying customers by email and arranging returns and refunds all recalled products.

Separately, Natures Supplement Inc. recalled 260 bottles of Vegetable Vigra 200mg capsules tainted with sildenafil and distributed in Florida to consumers by a third-party company. The product is marketed as a natural male enhancement and packaged in a bottle with a green label. The Oceanside, Calif., firm is notifying its distributor by mail and is arranging for returns of the products.

Agritek buys into supplement marketing

Agritek Holdings Inc., a real estate investment firm focused on the medicinal sector, closes an agreement to acquire Performance Nutrition Center LLC, a 15-year-old nutrition and supplement company in Orange County, Calif., with a revenue stream of close to $600,000. Agritel on Sept. 20 said Performance Nutrition sells exclusive supplement product lines through a “high traffic” retail location in Laguna Hills and online through eBay and Amazon stores. The deal will provide Agritek a foothold in online store fronts and a gateway to launch wellness products and brands, the firm said, without disclosing financial details of the transaction expected to close in October.

Astaxanthin gets Non-GMO verification

Israel firm Algatech Ltd. announces its astaxanthin oleoresin sourced from haematococcus pluvialis microalgae powder is the first astaxanthin to receive verification by Non-GMO Project Inc. “Consumers are actively seeking non-GMO products, so having the Non-GMO Project verify our line in accordance with its strict standards provides our partners added value on top of the existing USDA organic, GMP, kosher and halal certifications, said Algatech CEO Hagai Stadler in the firm's Sept. 19 statement. Algatech, which cultivates its microalgae in Israel’s Arava desert, supplies astaxanthin to manufacturers of supplements, food and beverages.

Oxylent in capsules

Vitalah Inc.'sfour Oxylent encapsulated products unveiled at the 2017 Natural Products Expo East Trade Show in Baltimore Sept. 14-16, comprise Multivitamin & Mineral + Superfood Formula for Men and one for women, Memory Formula + Cognizin and Restorative Formula + Antioxidants. The Watsonville, Calif., company on Sept. 13 said it adds the capsules to its line of Oxylent effervescent multivitamin drink blends containing of essential nutrients and other Oxylent formulas including prenatal and immune drink. “Along with our already successful effervescent formulas, we wanted to ensure we offer our valued customers with alternative delivery forms with unique packaging that represents organic superfoods, natural ingredients and wholesome lifestyle,” notes the firm.

FDA RECALLS CLASSIFIED THROUGH SEPT. 20
SEPT. 20: DRUG-CLASS I
New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected].
Code Information: UPC 557205060083, Exp 5/24/18.
Manufacturer:	Bestherbs Coffee LLC, Arlington, TX
Recalled by:	Bestherbs Coffee two or more of email, fax, letter, press release, telephone or visit on July 17, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Recalling firm distributed to 2 consignees in TX; however recalling firm reported that product is then distributed U.S. nationwide to consumers via individuals or internet; 6,250 packets.
Reason:	Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. (FDA previously in 2017 found ED drugs and other pharma ingredients in other coffee products available in the US). (Also see "Re-inspection Fees, Spiked Coffee, Recalls: Health And Wellness Industry News" - HBW Insight, 7 Aug, 2017.)
Recall numbers:	D-1144-2017
DRUG-CLASS I
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Code: a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020.
Manufacturer:	N/A
Recalled by:	Chiavna Saffron LLC, Huntersville, NC, by press release on July 21, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Nationwide US; 211 bottles; 339 boxes.
Reason:	Marketed without an approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil. (Drugs indicated for erectile dysfunction are the most common pharmaceuticals found in products fraudulently marketed as dietary supplements). (Also see "Regulatory Problems Mount For Supplement Firm Following Recall" - HBW Insight, 1 Aug, 2017.)
Recall numbers:	D-1145-2017
FOOD-CLASS II
1) Rugby Calcionate Syrup, One Pint (473 mL); 2) Rugby Cerovite Liquid, 8 oz. 236ML; 3) Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL; 4) Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL; 5) Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL; 6) Rugby Ferrous Sulfate Liquid One Pint, (473 mL); 7) Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL); 8) Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL); 9) Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL); 10) Major CertaVite Liquid, 8 oz. (236 mL); 11) Major D-Vita Drops, 1 2/3 oz (50 mL); 12) Major Ferrous Drops, 1 2/3 oz (50 mL); 13) Major Poly-Vita Drops, 1 2/3 oz (50 mL); 14) Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL); 15) Major Tri-Vita Drops, 1 2/3 oz (50 mL); 16) Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL); 17) Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) UPC Number: 0 96295 12862 8.
Code: All unexpired lots for each; 1) UPC Number: 0 05362 77085 1,; 2) UPC Number: 00536-2790-59,; 3) UPC Number: 0 05368 40080 6; 4) UPC Number: 00536-0710-80; 5) UPC Number: 0 05360 16097 0; 6) UPC Number: 0 05360 65085 8; 7) UPC Number: 0 05368 45080 1; 8) UPC Number: 0 05368 53080 0; 9) UPC Number: 0 05368 50180 0; 10) UPC Number: 3 09045 02309 9; 11) UPC Number: 3 09046 27350 9; 12) UPC Number:3 09046 27350 9; 13) UPC Number: 3 09045 09950 6; 14) UPC Number: 3 09045 10050 9; 15) UPC Number: 3 09046 27450 6; 16) UPC Number: 096295128611.
Manufacturer:	The Harvard Drug Group, Livonia, MI
Recalled by:	Harvard Drug Group by press release on Aug. 2, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305; 1) 5,771 units; 2) 65,611; 3) 105,628; 4) 27,011; 5) 30,782; 6) 34,280; 7) 113,829; 8) 117,098; 9) 52,897; 10) 61,262; 11) 27,447; 12) 63,005; 13) 27,735; 14) 33,390; 15) 10,074; 16) 3,840; 17) 1,728.
Reason:	The distribution firms Leader Brand, Major Pharmaceuticals and Rugby Laboratories, subsidiaries of Harvard Drug Group, are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. (The Leader, Major and Rugby products are among the supplement and Rx and OTC drug products affected by potentially contaminated water used by contract manufacturer PharmaTech LLC.) (Also see "PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN" - HBW Insight, 16 Aug, 2017.)
Recall numbers:	F-3515-2017 throu8gh F-3531-2017
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.

From the editors of The Tan Sheet. Our dietary supplement industry coverage now is published in the Rose Sheet, with articles emailed to readers daily and available on this page of the Rose Sheet website.