FDA Recalls (2006)

Year 2007 2006 2005 2004 2003 2002

U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2006 to 12/31/2006

Nutritech Calcium Complex Powdered Dietary Supplement
Various supplement tablets by Heartland Repack Services, LLC, Toledo, OH
BLAINE brand UroMag, Magnesium Oxide
MRI brand Elemental Potassium and Liquimins brand Ionic Potassium
Pharmagenx brand Ventilean dietary supplement and Pharmagenx brand Ventilean LipoGels
NOW Kidvits, Animal-Shaped Chewables
Nature's Treat Energy Plus dietary supplement
MAX TEN DIETARY SUPPLEMENT
Citrucel FiberShake Chocolate .38 oz Packets

October 25, 2006

PRODUCT	Nutritech Calcium Complex Powdered Dietary Supplement "ALL ONE Calcium Complex", 8.5 ounce jug, Recall # F-005-7
CODE	Lot numbers: 12420/01/07, 04529/06/07, 03526/03/07, 09421/10/06, 04431/05/06, 03409/03/06 and 07425/08/06
RECALLING FIRM/MANUFACTURER	Recalling Firm:Nutritech Corporation, Santa Barbara, CA, by press release and letter beginning on May 12, 2006. Manufacturer:Northridge Laboratories Inc., Chatsworth, CA. Firm initiated recall is ongoing.
REASON	The label of the product is false and misleading, since it represented the product as "Vegan" when in fact it contained milk derivatives.
VOLUME OF PRODUCT IN COMMERCE	21,028
Distribution	Nationwide

PRODUCT	a) CALCIUM CARBONATE 600 MG Tablets, 250 count bags, NDC #61392051125 & 30 count boxes, NDC #61392051130 Supplement, Recall # F-013-7; b) CALCIUM CARBONATE 600 W/D 600MG Tablets, 250 count bags. NDC #61392044525 & 30 count boxes NDC #61392044530 Supplement, Recall # F-014-7; c) CALCIUM W/D 250MG/125IU Tablets, 30 count boxes (NDC #61392004730) & 60 count boxes (NDC #61392004760) Supplement, Recall # F-015-7; d) CALCIUM W/D 500MG/200IU Tablets, 30 count boxes (NDC #61392065330), supplement, Recall # F-016-7; e) CERTAGEN Tablets, 250 count bags (NDC #61392056025) & 30 count boxes (NDC #61392056030) Supplement, Recall # F-017-7; f) FERROUS SULFATE 325MG tablets GREEN, 60 count boxes (NDC #61392012760), Supplement, Recall # F-018-7; g) FERROUS GLUCONATE 324mg Tablets, 250 count bags (NDC#61392022625) & 30 count boxes (NDC #61392022630) Supplement, Recall # F-019-7; h) MAGNESIUM OXIDE 400MG Tablets, 30 count boxes (NDC #61392097930) Supplement, Recall # F-020-7; i) MULTIVITAMINS, THER W-MINERALS Tablets, 250 count bags (NDC #61392035125) & 30 count boxes (NDC #61392035130) Supplement, Recall # F-021-7; j) MULTIVITAMINS, THERAPEUTIC Tablets, 250 count bags (NDC #61392035025) & 30 count boxes (NDC #61392035030) Supplement, Recall # F-022-7; k) ONE TAB DAILY Tablets, 250 count bags (NDC #61392093825) & 30 count boxes (NDC #61392093830) Supplement, Recall # F-023-7; l) ONE TAB DAILY W/IRON Tablets, 250 count bags (NDC #6139201525) & 30 count boxes (NDC #6139201530) Supplement, Recall # F-024-7; m) OYSTER SHELL 500mg Tablets, 250 count bags (NDC #61392000625) Supplement, Recall # F-025-7; n) VITAMIN B1 (THIAMINE) 100MG Tablets, 250 count bags (NDC #61392002125) & 30 count boxes (NDC #61392002130) Supplement, Recall # F-026-7; o) VITAMIN B1 (THIAMINE) 50MG Tablets, 250 count bags (NDC #61392050625) & 30 count boxes (NDC #61392050630) Supplement, Recall # F-027-7; p) VITAMIN B12 100MCG Tablets, 250 count bags (NDC #61392057525) & 30 count boxes (NDC #61392057530) Supplement, Recall # F-028-7; q) VITAMIN B12 500MCG Tablets, 250 count bags (NDC #61392050325) & 30 count boxes (NDC #61392050330) Supplement, Recall # F-029-7; r) VITAMIN B6 (PYRIDOXINE) 100MG Tablets, 250 count bags (NDC #61392080625) & 30 count boxes (NDC #61392080630) Supplement, Recall # F-030-7; s) VITAMIN C 250MG Tablets (ASCORBIC ACID), 250 count bags (NDC #61392015525) & 30 count boxes (NDC #61392015530) Supplement, Recall # F-031-7; t) VITAMIN C 500MG Tablets (ASCORBIC ACID), 250 count bags (NDC #613920155625), 30 count boxes (NDC #613920155630) and 60 count boxes NDC #613920155660) Supplement, Recall # F-032-7; u) VITAMIN E 200IU Capsules, 250 count bags (NDC #61392050425) and 30 count boxes (NDC #61392050430) Supplement, Recall # F-033-7; v) VITAMIN E 400IU Capsules, 250 count bags (NDC #61392002225) and 30 count boxes (NDC #613920022230) Supplement, Recall # F-034-7
CODE	a) K43303R25, and K43303R30; b) K34640A25, K35453A25, K35978B25, K35978F25, K36370A25, K41776A25, K36712B25, K37095A25, K37569A25, K38138A25, K38769B25, K40096A25, K40179A25, K40704A25, K35433B30, K35670A30, K35670B30, K35978A30, K35978C30, K35978D30, K35978E30, K36370B30, K41776B30, K36712A30, K37083A30, K37095B30, K3569B30, K37569C30, K38138B30, K3555A30, K38555B30, K38769A30, K38769C30, K39419A30, K39419B30, K40096B30, K40179B30, K40278A30, K40564A30, K40704B30 & K41071A30; c) K, 39012A30, K39012B30, K39330A30 and K33952A60; d) K41957A30 and K41958A30; e) K38903B25, K40093A25, K40093C25, K40473B25, K41423A25, K41423C25, K42681A25, K38902A30, K38932A30, K38903C30, K39486A30, K40093B30, K40473A30, K41423B30, K41423D30, K41968A30, and K46281B30; f) K42757R60; g) K37485R25, K37794A235, K378123A25, K37485R30, K37794A30, K39328A30, K39328B30, K37823A30, and K42403A30; h) K40645R30, K42387R30; i) K41984A25, K41984B30; j) K41822A25, K36803A25, K41822B30, K38340A30, K38991A30; k) K41044A25, K35609A30, K36127A30, K36816A30; l) K36774A25, K4112A25, K36774B30, K42580A30, K39331A30, K3931B30, K40430A30, K40430B30, K41122B30; m) K34599A25; n) K40798R25, K42199R25, K42836R25, K40316R25, K43420R25, K40798R30, K42198R30, K42199R30, K42836R30, K40316R30, K43420R30; o) K41612A25, K39063R25, K39443A25, K40569A25, K40863A125, K41612B30, K39063R30, K39443B30, K39734A30, K39734B30, K40569B30, K40863B30; p) K36989R25, K42145A25, K37341R25, K37714R25, K38105A25, K38537A25, K40570A25, K41255A25, K36989R30, K42145B30, K37341R30, K37714R30, K38105A30, K38537B30, K38537C30, K39735A30, K39735B30, K40415A30, K40570B30, K40803A30, K41255B30; q) K36718A25, K36948A25, K36948B25, K37579A25, K38282B25, K36718A30, K38094A30, K38094D30, K39931A30, K39931A30, K39931A30, K39931B30, K40495A30, K40495C30, K41082A30; r) K40657R25, K41102R25, K41677R25, K42220R25, K42653R25, K42796R25, K409657R30, K41102R30, K41677R30, K92220R30, K4653R30; s) K35951R25, K36306R25, K36628A25, K41949A25, K37738B25, K39721A25, K40034A25, K40034C25, K40034E25, K40364B25, K40482B25, K40701A25, K35951R30, K36306R30, K36628A30, K37738A30, K37738C30, K37763A30, K37763B30, K39807A30, K40034B30, K40034D30, K40034F30, K40364A30, K40482A30, K40701B30, K35951R60, K36306R60; t) K41331R25, K41722R25, K40876R30, K41331R30, K41721R30, K41829R30, K40876R60, K41331R60, K41722R80, K41829R69; u) K40659R25, K41519R25, K42033R25, K42299R25, K40659R30, K41519R30, K42033R30, K42299R30; v) K40780R25, K41412425, K41824R25, K421825R25, K42296R25, K42823R25, K43421R25, K40780R30, K41412R30, K411824R30, K41826R30, K42296R30, K42754R30, K42823R30, K43421R30
RECALLING FIRM/MANUFACTURER	Heartland Repack Services, LLC, Toledo, OH, by fax, telephone and letter dated July 28, 2006. Firm initiated recall is ongoing. Heartland Repack Services, LLC, Toledo, OH, by fax, telephone and letter dated July 28, 2006. Firm initiated recall is ongoing.
REASON	There is a possibility of multiple product packaging mix-ups involving nutritional supplements, OTC drugs and prescription drugs which were distributed.
VOLUME OF PRODUCT IN COMMERCE	126,125 cases
Distribution	Nationwide

PRODUCT	BLAINE brand UroMag, Magnesium Oxide 140 mg, Magnesium Dietary Supplement, Capsule form, 100 count bottle, UPC barcode # 3 01650 05401 7, Recall # F-228-6
CODE	Lot 04M030, Exp. date 12/07
RECALLING FIRM/MANUFACTURER	Ultratab Laboratories Inc., Highland, NY, by telephone on March 20, 2006 and by letter and e-mail on March 22, 2006. Firm initiated recall is complete.
REASON	The own label distributor received a complaint of 1 foreign capsule found in a bottle of UroMag Magnesium Oxide 140 mg Magnesium Dietary Supplement, lot 04M030. Analysis of the foreign capsule confirmed it to be Selegiline HCl 5 mg, a prescription product intended for the treatment of Parkinson's disease.
VOLUME OF PRODUCT IN COMMERCE	10,044 - 100 count bottles (1,018,368 capsules)
Distribution	KY

PRODUCT	Liquid potassium supplement under the following brands: a) MRI brand Elemental Potassium, 99mg, Net 2 Fl. Oz., b) Liquimins brand Ionic Potassium, 99mg, Net 2 Fl. Recall # F-227-6
CODE	Lot numbers: 073-502, 073-504, 073-506, and 073-602
RECALLING FIRM/MANUFACTURER	Mineral Resources International, Ogden, by telephone on March 23, 2006 and by letter on April 12, 20006, firm initiated recall is ongoing.
REASON	Dietary supplement may be contaminated with Aspergillis sydowii and yeast.
VOLUME OF PRODUCT IN COMMERCE	8,469 bottles
Distribution	UT, Netherlands, Philippines, and UK

PRODUCT	a) Pharmagenx brand Ventilean dietary supplement sold as a liquid in 4 ounce (120 ml) and 8 ounce (240 ml) plastic bottles. The liquid product was also distributed in plastic ampoules labeled 'VENTILEAN 10 ml (2Srv.)' The ampoules were given away at trade shows, by retail stores or in small amounts to individual consumers, Recall # F-166-6; b) Pharmagenx brand Ventilean LipoGels (soft gelatin capsules). The gelatin capsules are sold in 48 count and 96 count plastic bottles, Recall # F-167-6
CODE	All codes
RECALLING FIRM/MANUFACTURER	Pharmagenx AKA Vita Shots, San Marcos, CA, by letters on April 1, 2005. Firm initiated recall is ongoing.
REASON	Some lots of the product were found to contain Clenbuterol a drug not approved for human use in the United States.
VOLUME OF PRODUCT IN COMMERCE	2,400 bottles and 100 cases of ampoules
Distribution	Nationwide, Canada, Mexico, Ecuador, Nigeria and Japan

PRODUCT	NOW Kidvits, Animal-Shaped Chewables, A Dietary Supplement; packaged in 50 Lozenges and 100 Lozenges bottles/12 bottles per case; UPC 33739-03870 and 33739-03872, Recall # F-168-6
CODE	All lots of Kid Vits product numbers 3870 (50 lozenge bottles) and 3872 (100 lozenge bottles)
RECALLING FIRM/MANUFACTURER	Recalling Firm: NOW Foods, Bloomingdale, IL, by letter dated October 3, 2005. Manufacturer: Kabco, Inc, Amityville, NY. Firm initiated recall is complete.
REASON	The product contains Aspartame but does not list Aspartame as an ingredient on the label and does not bear the phenylalanine.
VOLUME OF PRODUCT IN COMMERCE	12,362 bottles
Distribution	NC, CA, PR, and Internationally

PRODUCT	Nature's Treat Energy Plus dietary supplement containing 23.4 mg ephedrine group alkaloids and 79.2mg caffeine alkaloids per serving. Product is packaged in white plastic bottles with white screw top caps consisting of 120 capsules per bottle for oral administration. Advertised dosage is 2 capsules twice daily. The 120ct. bottles are further packaged into cases of 24 bottles. These cases are identified by the labeling: ''*Formula #1 Capsules120 capsules/bottle24 bottles/case*'', Recall # F-103-6
CODE	Lot numbers: 205108 and 205109 (only lots manufactured)
RECALLING FIRM/MANUFACTURER	Recalling Firm: Nature's Treat, Inc, Gainesville, TX, by telephone on August 17, 2005. Manufacturer: Summa RX Laboratories, Inc, Mineral Wells, TX, firm initiated recall is ongoing.
REASON	Recalling Firm: Nature's Treat, Inc, Gainesville, TX, by telephone on August 17, 2005. Manufacturer: Summa RX Laboratories, Inc, Mineral Wells, TX, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE	480 (120 count) bottles
Distribution	OR.

PRODUCT	Max Ten capsules in amber or white, rigid, polypropylene bottles with screw on lid and red, orange and yellow label, labeled in part: ''*MAX TENDIETARY SUPPLEMENT** Product contains Ma-Huang Extract (10mg naturally-occurring ephedra alkaloids). Product comes in both 30 count and 90 count sizes. Bar Code #6 11797 32754 8 (30 count) and #6 11797 32753 8 (90 count), Recall # F-104-6
CODE	Lot number: 07G05 and Lot number 25K05 (only two lots manufactured).
RECALLING FIRM/MANUFACTURER	Recalling Firm: Maxlabs, Houston, TX, by letter on December 8, 2005. Firm initiated recall is ongoing.
REASON	This product contains ephedrine alkaloids.
VOLUME OF PRODUCT IN COMMERCE	20,454 units
Distribution	Nationwide.

PRODUCT	Citrucel FiberShake Chocolate .38 oz Packets which are distributed individually as well as in a 5 count starter kits. Methylcellulose (a non-allergenic fiber) 2g...Bulk-forming laxative, Uses*, Warnings, Directions, Inactive ingredients*, Recall # D-127-6
CODE	All lots: Case lots with have an A or N() after the lot number: Lot -- Exp. Date: 05A075 -- MAR-07; 05A076 -- MAR-07; 05B212 -- APR-07; 05F002 -- JUL-07; 05B210 -- APR-07; 05B211 -- APR-07; 05D056 -- MAY-07; 05A049 -- MAR-07; 05F001 -- JUL-07; 05A045 -- FEB-07; 05A046 -- MAR-07; 05A048 -- MAR-07; 05C162 -- MAY-07; 05C164 -- MAY-07; 05F003 -- JUL-07; 05C160 -- APR-07; 05C161 -- APR-07; 05C163 -- MAY-07; 05D057 -- MAY-07
RECALLING FIRM/MANUFACTURER	Recalling Firm: GlaxoSmithKline, Parsippany, NJ, by letter on December 8, 2005. Manufacturer: JB Laboratories, Inc., Holland, MI. Firm initiated recall is ongoing.
REASON	During stability testing of non-commercial/undistributed lots, packets were found to exceed "Total Coliforms" specification of NMT 10 cfu/g at the 12 month station. All commercial lots are being recalled.
VOLUME OF PRODUCT IN COMMERCE	4,429,192 packets
Distribution	Nationwide and PR.

FDA Recalls (2006)

U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2006 to 12/31/2006

FDA Website: www.FDA.gov