Year 2007 2006 2005 2004 2003 2002
U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2007 to 7/15/2007
- FiberChoice plus Multivitamins Fiber Supplement chewable tablets.
- RHINO V MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement
- MULTIVITAMINS, THER W-MINERALS TABLET; MULTIVITAMINS, THERAPEUTIC TABLET; OYSTER SHELL 500MG TABLET
- LIVIRO3 Natural Energy Enhancer Nutritional Supplement
- LEVIROL Sexual Performance Formula Dietary Supplement
- Various Vitamins and Minerals (Heartland Repack)
- Meijer brand Natural Calcium with Vitamin D USP tablets
- Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend, 60 capsules
- Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor
- Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg
- Garden Greens GojiSplash Goji Berry juice drink active polysaccharide, Super antioxidants
- NASUTRA Herbal Supplement for Men
- Neophase Natural Sex Enhancer formula for MEN Herbal Supplement
- Genesis Today Goji 100 Liquid Dietary Supplement 4 oz. and 32 oz. bottles
July 11, 2007
| PRODUCT |
FiberChoice plus Multivitamins Fiber Supplement chewable tablets. Contains
Insulin fiber (2g per tablet) along with 13 essential vitamins and minerals. 90
count plastic bottles, (16 oz.), UPC#5714500581, Recall # F-432-7 |
| CODE |
Lot numbers: 06L062, 06L063,06L102, 06M075, 07A001,07A002, 07A003,07A004,07A005,
07A006, 07A007, 07A008, 07A009,
07A051,07A052,07A053,07A054,07A055,07A068,07A069, 07A070,07A072,
07A073,07A074,07A075,07A076,07A077,07A078,07A080, 07A116, 07A117,07A118, 07A119,
07A120 87673901 (display) |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Glaxo Smith Kline, Parsippany, NJ, by press release on March 20, 2007 and by letter on March 21, 2007.
Manufacturer: Amerilab Technologies, Inc., Plymouth, MN. Firm initiated recall is ongoing. |
| REASON |
GSK purchased CNS Inc, the marketer of the Fiber Choice Fiber Supplement line of
products, on 12/19/2006. During a review of all formulation and manufacturing
procedures, it was discovered that the Vitamin A use in FiberChoice with
Multivitamins Fiber Supplement contains undeclared fish gelatin in the raw
material. |
| VOLUME OF PRODUCT IN COMMERCE |
145,134 bottles |
| Distribution |
Nationwide |
Back to Top
June 27, 2007
| PRODUCT |
RHINO V MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement, 5
and 15 capsules blister pack cartons, Recall # D-817-2007 |
| CODE |
N/A |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Cosmos Trading, Los Angeles, CA, by telephone, fax and letter on March 12, 2007, and by press release on March 16, 2007.
Manufacturer: MegaCare, Inc., Las Vegas, NV. Firm initiated recall is ongoing. |
| REASON |
Unapproved New Drug; Product found to contain Aminotadalafil an analogue of
tadalafil, a drug product to treat erectile dysfunction. |
| VOLUME OF PRODUCT IN COMMERCE |
4,976 retail units
|
| Distribution |
CA and NV |
Back to Top
May 30, 2007
| PRODUCT |
Part of a larger recall:
jjj) MULTIVITAMINS, THER W-MINERALS TABLET, 250 count bags
(NDC #61392035125) & 30 count boxes (NDC #61392035130), OTC,
Recall # D-637-2007;
kkk) MULTIVITAMINS, THERAPEUTIC TABLET, 250 count bags (NDC #61392035025)
& 30 count boxes (NDC #61392035030), OTC, Recall # D-638-2007;
zzz) OYSTER SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
30 count bingo card (NDC #61392000639), 30 count boxes (NDC #61392000630)
& 60 count boxes (NDC #61392000660), OTC, Recall # D-653-2007; |
| CODE |
jjj) All Lot Codes: U36931A25, U37528B25, U38395C25, U39804A25, U40236A25,
U40436B25, U40436C25, U40628B25, U40628C25, U41021A25, U41440A25,
U43047a25, C43469B25, C42753B25, C43675B25, C43675E25, U36186A30,
U36931B30, U37528A30, U37845A30, U38395A30, U38395B30, U38395E30,
U38395D30, U38893A30, U37528C30, U37528D30, U39804B30, U37528E30,
U37528F30, U40236C30, U40236B30, U40436A30, U40436D30, U40628A30,
U40628D30, U41021B30, U41440B30, U42002A30, U42671A30, U43047B30,
C43469A30, C42753A30, C43675C30, C43675D30;
kkk) All Lot Codes: U36448A25, U36448D25, U37144A25, U37144B25, U38483A25,
U40287A25, U40990A25, U41274A25, U41994A25, C42793B25, U42666A25,
U36471B30, U36471A30, U36448C30, U36448B30, U37144C30, U37593A30,
U37144D30, U38483B30, U38483C30, U37905A30, U38986A30, U39986A30,
U40127A30, U40990B30, U41274B30, U41994B30, C42793A30, C42793C30,
U42666B30, C43230A30, U42995A30, C43230B30;
zzz) All Lot Codes: U36507B25, U36922B25, U37139B25, U39260A25,
U37139E25, U36922D25, U40314A25, U40314D25, U40953A25,
U42672A25, 36457, 006E0508, 006F0513, 006G0507, 006H0509,
006j0504, 006J0516, 006K0517, 39009, 006L0532, 006M0517, 006A0624,
006A0627, 066B0615, 006D0602, 006E0603, 006F0633, 006E0602, 43204,
U36507A30, U36922A30, U36242B30, U36922C30, U37139C30, U38852A30,
U39260B30, U39022A30, U38147A30, U37882C30, U38852B30, U40000A30,
U39803B30, U40000B30, U40314B30, U40314E30, U40953C30, U43268B30,
U36242A60, U37139A60, U37139D60, U37882A60, U37882B60, U39803A60,
U40314C60, U40953B60, U41563A60, U41941A60, U41630A60, U42672B60,
U43268A60 |
| RECALLING FIRM/MANUFACTURER |
Heartland Repack Services, LLC, Toledo, OH, by telephone between February 14, 2007 and February 20, 2007. Firm initiated recall is ongoing. |
| REASON |
Misbranding. There is the possibility of multiple product packaging mix-ups. An
OTC drug, Rx drug ,or nutritional supplement other than what is indicated on the
product labeling, may be inside the packaging. |
| VOLUME OF PRODUCT IN COMMERCE |
566,734,636 units |
| Distribution |
Nationwide |
Back to Top
May 23, 2007
| PRODUCT |
LIVIRO3 Natural Energy Enhancer Nutritional Supplement, 450mg Capsules, packaged
in boxes of 10 capsules and bottles of 20 capsules, Recall # D-796-2007 |
| CODE |
The firm indicated the distributed 5 lots(#1-5) Lot#1 Exp. Date 03/2006, Lot#2
Exp. Date 11/2008, Lot#3 Exp. Date 0/2009, Lot#4 Exp. Date 07/2009 & Lot#5 Exp. Date 07/2009 NOTE: THIS IS WHAT WAS FOUND ON SAMPLE COLLECTED- Underneath the aluminum try that contains all 10 capsules of LIVIRO3 (found inside box), there are lot codes and expiration dated imprinted on it. The lot code for the FDA sample is LOT 0730 EXP 07/30/2009. There might be other lot codes since it appears that the lot code correspond with the expiration date. Note: Other codes pending |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Ebek, Inc, Los Angeles, CA, by telephone on January 10, 2007, press release on January 19, 2007 and January 29, 2007, and by letters beginning January 29, 2007.
Manufacturer: West Coast Laboratories Inc, Gardena, CA. Firm initiated recall is ongoing. |
| REASON |
Unapproved New Drug; product to contain the undeclared ingredient Tadalafil, the
active pharmaceutical ingredient in an FDA approved drug used to treat erectile
dysfunction. |
| VOLUME OF PRODUCT IN COMMERCE |
278,260 capsules |
| Distribution |
Nationwide |
Back to Top
May 23, 2007
| PRODUCT |
LEVIROL Sexual Performance Formula Dietary Supplement, a proprietary blend of:
Epimedium (Epimedium sagittatum leaf), 2 Capsules per pack, Recall #
D-795-2007 |
| CODE |
Lot # 0606332 expires 06/09 & Lot # 0605143 expires 05/09 |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Levirol, LLC, Tempe, AZ, by letter on January 28, 2007, and February 12, 2007.
Manufacturer: Bactolac Pharmaceutical, Inc, Hauppauge, NY. Firm initiated recall is ongoing. |
| REASON |
Unapproved New Drug; product found to contain the undeclared ingredient
Aminotadalafil, an analogue of Tadalafil, the active pharmaceutical ingredient
found in an FDA approved drug used for erectile dysfunction. |
| VOLUME OF PRODUCT IN COMMERCE |
22,658 capsules (11,329 x2 capsule packages) |
| Distribution |
Nationwide and Canada |
Back to Top
May 16, 2007
| PRODUCT |
a) FERROUS GLUCONATE 324MG TABLET, 250 count bags (NDC #61392022625),
30 count bingo card (NDC #61392022639) & 30 count box (NDC #61392022630),
OTC, Recall # F-242-7;
b) FERROUS SULFATE 325MG TABLET GREEN, 250 count bags
(NDC #61392012725), 30 count bingo card (NDC #61392012739),
30 count boxes (NDC #61392012730), 60 count boxes (NDC #61392012760)
& 90 count boxes (NDC #61392012790), OTC, F-243-7;
c) ONE TAB DAILY TABLET, 250 count bags (NDC #61392093825) &
30 count boxes (NDC #61392093830), OTC, Recall # F-244-7;
d) ONE TAB DAILY W/ IRON TABLET, 250 count bags (NDC #61392001525)
& 30 count boxes (NDC #61392001530), OTC, Recall # F-245-7;
e) OYSTER SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
30 count bingo card (NDC #61392000639), 30 count boxes (NDC #61392000630)
& 60 count boxes (NDC #61392000660), OTC, Recall # F-246-7;
f) VITAMIN B1 (THIAMINE) 50MG TABLET, 30 count bingo card (NDC #61392050639),
OTC, Recall # F-247-7;
g) VITAMIN B12 1000MCG TABLET, 30 count bingo card (NDC #61392057539), OTC,
Recall # F-248-7;
h) VITAMIN B12 100MCG TABLET, 30 count bingo card (NDC #61392050239)
& 30 count boxes (NDC #61392050230), OTC, Recall # 249-7;
i) VITAMIN B12 500MCG TABLET, 250 count bags (NDC #61392050325),
30 count bingo card (NDC #61392050339) & 30 count boxes (NDC #61392050330),
OTC, Recall # F-250-7;
j) VITAMIN C 250MG TABLET (ASCORBIC ACID), 250 count bags
(NDC #61392015525), 30 count bingo card (NDC #61392015539),
30 count boxes (NDC #61392015530), OTC, Recall # F-251-7;
k) CALCIUM CARBONATE W/D 600MG TABLET, Recall # F-252-7;
l) CALCIUM W/D 250MG/125IU TABLET, 250 count bags (NDC #61392004725),
30 count bingo card (NDC #61392004739), & 30 count boxes (NDC #61392004730),
OTC, Recall # F-253-7;
m) CALCIUM W/D 500MG/200IU TABLET, 250 count bags (NDC #61392065325),
30 count bingo card (NDC #61392065339), 30 count boxes (NDC #61392065330),
60 count boxes (NDC #61392065360), OTC, Recall # F-254-7
|
| CODE |
a) All Lot Codes: U39727B25, U39727C25, U41009A25, U41946B25, 226M0501,
226A0646, 226E0617, U39727A30, U41009B30, U41946A30;
b) All Lot Codes: U37269B25, U37519A25, U37519C25, U38039B25, 127D0512,
127F0513, 127G0503, 127H0503, 127j0504, U36642C30, U36781C30,
U36781D30, U36781F30, U37519B30, U38346B30, U38346C30, U38346D30,
U37519D30, U38039C30, U36642A60, U36781A60, U36781B60, U36642E60,
U36781E60, U37269A60, U37146A60, U38346A60, U38039D60, U38346E60,
U36642B90, U36642D90, U38039A90;
c) All Lot Codes: U36554B25, U36271D25, U36554C25, U37557B25, U38195B25,
U38944A25, U40237A25, U40434A25, C40481B25, U41252A25, U41252B25,
C41967B25, C42641B25, C43073B25, U36271A30, U36271B30, U36271C30,
U36554A30, U37009A30, U36779A30, U36554D30, U36554E30, U37557A30,
U37809A30, U38042A30, U38042B30, U38195A30, U38943A30, U38603A30,
U38603B30, U38944B30, C39966A30, U38943B30, U39177A30, C39966B30,
C40481, U40237B30, U40434B30, C41967A30, C41967C30, C41967D30,
U41991A30, C42641A30, C43073A30, C43310A30, C43310B30;
d) All Lot Codes: U36246A25, U37140B25, U37807B25, U38679A25, U39855B25,
U39855C25, U41174A25, U36246B30, U36246C30, U37140A30, U37807A30,
U37807C30, U38389A30, U38679B30, U37140C30, U37807D30, U38389B30,
U39855A30, U39855D30, U40601B30, U41174B30, U43046A30;
e) All Lot Codes: U36507B25, U36922B25, U37139B25, U39260A25, U37139E25,
U36922D25, U40314A25, U40314D25, U40953A25, U42672A25, 36457, 006E0508,
006F0513, 006G0507, 006H0509, 006j0504, 006J0516, 006K0517, 39009, 006L0532,
006M0517, 006A0624, 006A0627, 066B0615, 006D0602, 006E0603, 006F0633,
006E0602, 43204, U36507A30, U36922A30, U36242B30, U36922C30, U37139C30,
U38852A30, U39260B30, U39022A30, U38147A30, U37882C30, U38852B30,
U40000A30, U39803B30, U40000B30, U40314B30, U40314E30, U40953C30,
U43268B30, U36242A60, U37139A60, U37139D60, U37882A60, U37882B60,
U39803A60, U40314C60, U40953B60, U41563A60, U41941A60, U41630A60,
U42672B60, U43268A60;
f) All Lot Codes: 39157, 506M0540;
g) All Lot Codes: 37002, 37235, 37683, 37897, 575k0531, 575A0621, 41079,
41584, 575E0622
h) All Lot Codes: 39156, 39940, 41078, U41634A30;
i) All Lot Codes: U41635A25, 38459, 39458, 503A0650, 41740, 42769, U41635B30;
j) All Lot Codes: U41007B25, C42424A25, 36191, 36588, 38994, 38995,
155M0517, 155C0613, U41007A30, C42426B30, C42424A30;
k) All Lot Codes: C41644A30;
l) All Lot Codes: U39848B25, U40168A25, U40604A25, U41177B25, U41177C25,
047k0508, 047L0533, 047M0520, 047A0612, 047B0645, 047EO632, 42845,
U38439A30, U38439B30, U38439C30, U39848A30, U39848C30, U40168B30,
U40604B30, U40604C30, U41177A30, U41177D30;
m) All Lot Codes: U40264A25, U40282A25, U40282D25, U40635A25, U40112D25,
U40282E25, U40635B25, U41876A25, U42232A25, U42569A25, U42603A25,
U43214D25, 653A0606, 653A0634, 653A0652, 653B0623, 653B0628, 653D0602,
653D0628, 653F0607, 653F0640, 653E0620, 653F0608, U40112C30, U40264B30,
U40264C30, U40264E30, U40264D30, U40282B30, U40282C30, U41876C30,
U41876D30, U42232C30, U42569C30, U42568A30, U42568B30, U43214B30,
U43214A30, U43214C30, U40112B60, U40112A60, U40635C60, U40810A60,
U41876B60, U42232B60, U42568C60, U42603B60, U42569B60, U43214E60 |
| RECALLING FIRM/MANUFACTURER |
Heartland Repack Services LLC, Toledo, OH, by telephone between February 14 and February 20, 2007. Firm initiated recall is ongoing. |
| REASON |
Misbranding. There is the possibility of multiple product packaging mix-ups. An
OTC drug, RX drug, or nutritional supplement, other than what is indicated on
the product labeling, may be inside the packaging. |
| VOLUME OF PRODUCT IN COMMERCE |
31,485,030 units= 2,140,500/250 count; 257,220/90 count; 4,043,400/60 count
& 25,043910/30 count |
| Distribution |
Nationwide |
Back to Top
April 18, 2007
| PRODUCT |
Meijer brand Natural Calcium with Vitamin D USP tablets, 1200 mg & D per serving, 300 coated caplets; UPC 4125003889; Recall # F-195-7 |
| CODE |
Lot: 5HN0384; Exp. 05/2009 |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: L. Perrigo Co., Allegan, MI, by email on January 31, 2007.
Manufacturer: Perrigo Company of South Carolina, Greenville, SC. Firm initiated recall is ongoing. |
| REASON |
The bottles may actually contain 400 IU Vitamin E gelcaps. |
| VOLUME OF PRODUCT IN COMMERCE |
3,228 bottles |
| Distribution |
MI |
Back to Top
April 11, 2007
| PRODUCT |
Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend, 60
capsules, Dr. Theo’s Cellular Health, Recall # F-173-7 |
| CODE |
All lots on the market at the time of the recall |
| RECALLING FIRM/MANUFACTURER |
Techmedica Health Inc., Grand Rapids, MI., by telephone beginning on May 9, 2006 and by letters on or about May 9, 2006 and June 23, 2006. Firm initiated recall is complete. |
| REASON |
The product is an unapproved new drug because the therapeutic claims on the
firm’s web site establish that the product is promoted for use in the cure, mitigation treatment or prevention of disease (diabetes). |
| VOLUME OF PRODUCT IN COMMERCE |
Not available |
| Distribution |
Nationwide |
Back to Top
April 4, 2007
| PRODUCT |
Pedia Sure with Fiber and FOS, enteral formula, Vanilla Flavor, Recall #
F-168-7 |
| CODE |
49304RE, use by 1 Feb 2008 |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH., by letter dated January 23, 2007 and by visit on January 24, 2007.
Manufacturer: Ross Products Division Abbott Laboratories, Casa Grande, AZ. Firm initiated recall is ongoing. |
| REASON |
PediaSure with Fiber and FOS, Enteral Formula does not meet label claim for
micronutrients – choline and 1-carnitine. |
| VOLUME OF PRODUCT IN COMMERCE |
289 cases/24/8 oz metal cans per case |
| Distribution |
AZ and CA |
Back to Top
March 28, 2007
| PRODUCT |
Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg, Hi-Tech Pharmaceuticals, Inc., 5015 B Unity Drive, Norcross, GA 30871, sold over-the-counter, labeled to contain a combination of herbal ingredients for use as an immune support booster. The primary ingredients (per tablet) listed on the product's labeling include the following: star anise extract, shikimic acid, and hypericum perforatum. The product's labeling recommends a dosage of 3 tablets for 10 days, followed by 1 tablet daily; manufactured January 2006. UPC of: 8 57084 00079 8, Recall # F-158-7 |
| CODE |
Lot # 06202044, expiration January 2009 |
| RECALLING FIRM/MANUFACTURER |
Hi Tech Pharmaceuticals, Norcross, GA, by letter on/about May 16, 2006. Firm initiated recall is ongoing. |
| REASON |
Dietary Supplement makes unapproved drug claim that it can prevent Bird Flu and
also fails to label one of its ingredients, star anise, properly. |
| VOLUME OF PRODUCT IN COMMERCE |
2,331 bottles containing 45 tablets per bottle |
| Distribution |
CA, MD, SD and TX |
Back to Top
March 7, 2007
| PRODUCT |
Garden Greens GojiSplash Goji Berry juice drink active polysaccharide, Super
antioxidants, helps support youth and vitality. Dietary supplement 30
servings/30 fl oz. (900 mL) plastic bottle, TC# A5821002, item N6004, UPC
3504606004, Recall # F-129-7 |
| CODE |
All lots that fail to declare sulfites as an ingredient. |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Windmill, West Caldwell, NJ, by letter beginning on January 3, 2007.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing. |
| REASON |
Undeclared sulfites at a level of 10.8 ppm were found during product
testing. |
| VOLUME OF PRODUCT IN COMMERCE |
39,836 bottles, 30 fl oz. each |
| Distribution |
Nationwide |
Back to Top
February 14, 2007
| PRODUCT |
NASUTRA Herbal Supplement for Men, proprietary blend of ten chinese herbs,
300mg, packaged in blisters of 2 capsules, Recall # D-438-7 |
| CODE |
Lot #: WP-505, WP904, WP1005, WP106, WP206, WPNA5O6 & WPNA7O6 |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Nasutra LLC, Beverly Hills, CA, by letter and press release on September 20, 2006.
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY. Firm initiated recall is ongoing. |
| REASON |
Unapproved New Drug; Product contains undeclared acetildenafil, an analogue of
sildenafil. |
| VOLUME OF PRODUCT IN COMMERCE |
1,105,000 X 2-capsule units |
| Distribution |
Nationwide and via the Internet |
Back to Top
February 7, 2007
| PRODUCT |
Neophase Natural Sex Enhancer formula for MEN Herbal Supplement, Proprietary Blend 700mg of Ginsenoside, Rhodiola crenulata root, Lysium chinesis fruit, Curculigo rhizome root, Licorice root, Snow lotus flower, Cuscuta chinesis and Cordyceps sinensis, 4 Soft capsules per bottle, Recall # D-435-2007
|
| CODE |
All Codes
|
| RECALLING FIRM/MANUFACTURER |
Recalling Firm:North American Distributor Group, LLC, San Francisco, CA, by e-mails and letters on July 17, 2006.
Manufacturer:Vigor Nutriceutical, Inc., Sun Prairie, WI. Firm initiated recall is complete.
|
| REASON |
Unapproved New Drug; product found to contain homosildenafil, an analogue of sildenafil.
|
| VOLUME OF PRODUCT IN COMMERCE |
396 bottles |
| Distribution |
CA |
Back to Top
January 10, 2007
| PRODUCT |
Genesis Today Goji 100 Liquid Dietary Supplement 4 oz. and 32 oz. bottles; UPC Code 83448 00060 (4oz.) and 83448 00056 (32oz.), Recall # F-085-7
|
| CODE |
Lot number: 0234F6 (4 oz.), Lot number: 0228F6 (32 oz.) and Lot number: 0273D6 (32 oz.)
|
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Genesis Today, Inc., Austin, TX, by telephone on October 16, 2006. and letter on October 25, 2006.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing.
|
| REASON |
Product contains undeclared Sulfites.
|
| VOLUME OF PRODUCT IN COMMERCE |
17,292 bottles |
| Distribution |
FL, NC, PA, VA, and Canada |
Back to Top
|
