FDA Consumer Health Product Recalls For May 4-25, 2016

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

MAY 4: DRUG-CLASS II
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Code: Lot 0110701
Manufacturer:	Mckesson Packaging Services, Concord, NC
Recalled by:	Mckesson Packaging Services by letter on April 12, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide; 1,676 boxes.
Reason:	Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Recall numbers:	D-0834-2016
FOOD-CLASS I
The Super Elixir By WelleCo Australia Alkalising Greens 150g/5.3 oz net, 300g/10.6 oz net Fine Powder welleco.com.
Code: Lot #0116015
Manufacturer:	Welle Pty Ltd., Cottesloe, Australia
Recalled by:	Welle Pty Ltd. by email on March 8, 2016. Voluntary recall is ongoing.
Distribution:	U.S. distribution via online sales to the following; CA, TX, MI, PA, NY, MD, FL, GA, MS, MO, NC, IL, OH, CT, WY, MN, KS, IN, VA, OR, NJ, AL, AZ, MA, RI, CO, TN, KY, UT, DE, WA, NH, OK No foreign distribution; 1224 (150g) and 6300 (300g) pouches.
Reason:	Welle Pty Ltd is recalling Wellco Super Elixir pouches because of potential Salmonella contamination
Recall numbers:	F-1069-2016
FOOD-CLASS II
1) Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules;.2) Elderberry 500 mg packaged in a white and orange bottle containing 60 capsules; 3) Gingko Biloba 60mg packaged in a white and orange bottle containing 120 capsules; 4) Goldenseal Root 500 mg packaged in a white and orange bottle containing 100 capsules; 5) Cranberry extract packaged in a white and orange bottle containing 90 capsules (all bottles have blue cap and white lettering).
Code Information: 1) Lot# 1966914, Batch# 582660, 2) Lot# 1966914, Batch# 582660; 3) Lot# 1969778, Batch# 582552, 4) Lot# 1961645, Batch# 579391, 5) Lot# 1961645, Batch# 579391.
Manufacturer:	NOW Foods, Bloomingdale, IL
Recalled by:	NOW Foods by press release on March 18, 2016. Voluntary recall is ongoing.
Distribution:	Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan; 1).8 bottles, 2) 2, 3) 57, 4) 2, 5) 12, 6) 3.
Reason:	Undeclared soy lecithin.
Recall numbers:	F-1129- through F-1133-2016
MAY 11: FOOD-CLASS III
Iowa Select Herbs LLC recalled 104 products, from acerola berry to alcohol-free sage leaf, and from ashwaganda root to yucca root (Also see "More Than 100 Herbal Supplements On Recall Under Consent Decree" - HBW Insight, 17 May, 2016.).
Code: all lots.
Manufacturer:	Iowa Select Herbs LLC, Cedar Rapids, IA
Recalled by:	Iowa Select Herbs by press release on Sept. 11, 2015. FDA-mandated recall is ongoing.
Distribution:	The recalled products were distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.
Reason:	Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.
Recall numbers:	F-1134- through F-1237-2016
MAY 18: FOOD-CLASS II
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz. The responsible name on the label is Nuwati Herbals Inc., House Springs, MO.
Code: all codes from 2011 through 2016
Manufacturer:	Nuwati Herbals Inc., Saint Charles, MO
Recalled by:	Nuwati Herbals by telephone on March 15, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide; 2,600 6 oz jars and 5,500 3 oz jars
Reason:	Product contains undeclared soy.
Recall numbers:	F-1331-2016
FOOD-CLASS I
Passion 4 Life 30 FL oz. Bottle
Code: Lot #15093, 15217, 15249, 15248, 15401, 15442, 16010.
Manufacturer:	Health 4 Life LLC, Encinitas, CA
Recalled by:	Health 4 Life by email on April 15, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide U.S. distribution through online sales. No foreign distribution; 8,382 bottles.
Reason:	Undeclared whey protein containing the allergens of milk and soy lecithin.
Recall numbers:	F-1324-2016
MAY 25: DRUG-CLASS III
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Code: Lot #: 5C344105, Exp 02/17.
Manufacturer:	Allegiant Health, Deer Park, NY
Recalled by:	Allegiant Health by two or more of email, fax, letter, press release, telephone or visit on Feb. 29, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide; a) 9816 bottles; b) 9648 bottles.
Reason:	Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Recall numbers:	D-0856-2016
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Code: Lot #: 10AN5
Manufacturer:	Keystone Laboratories Inc., Memphis, TN
Recalled by:	Keystone Laboratories by two or more of email, fax, letter, press release, telephone or visit on April 4, 2016. Voluntary recall is completed.
Distribution:	U.S. Including: MD and NJ; 7 cases of 12 bottles.
Reason:	Microbial Contamination of Non-Sterile Products: Failed Saureus test.
Recall numbers:	D-0853-2016
FOOD-CLASS II
Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in a six ounce, plastic, Royalty Bottle, with a 24mm vented flip top lid. item number: DES004Z. Sold under brands DESBIO and Seeking Health.
Code: Lot Number: 5101206 and 511100.
Manufacturer:	Empirical Laboratories Inc., Fort Collins, CO
Recalled by:	Empirical Laboratories by two or more of email, fax, letter, press release, telephone or visit on April 5, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide. No foreign or govt/VA/military consignee; 1,972 bottles.
Reason:	Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination.
Recall numbers:	F-1366-2016
MegaFood Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles UPC:5149410321 -Packaged 60 tablets; UPC:5149410322 -Packaged 120 tablets.
Code: Item Number:10321 (60 count) - Lot Numbers: 10321004 & 10321005 Item Number: 10322 (120 count)-Lot Number 10322004
Manufacturer:	FoodState Inc., Londonderry, NH
Recalled by:	FoodState by two or more of email, fax, letter, press release, telephone or visit om April 15, 2016. Voluntary recall is ongoing.
Distribution:	Nationwide; 2,953 bottles.
Reason:	Multi Vitamin label fails to have required warning statement for iron and child resistant cap.
Recall numbers:	F-1362-2016
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.