Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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May 23, 2007
07-21

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Russian Sea (Russkoe More) brand Atlantic Herring Jumbo Marinated, Net Wt. 1300 g (45.85 Oz). The product is packaged in an unopened two piece metal can. The product is labeled mostly in Russian with a white Nutrition Facts Panel label in English. --- According to New York State Department of Agriculture and Markets lab report, the fish are whole & 10-12 inches in length with five per can, UPC bar code 4 605561 000153, Recall # F-260-7
CODE
Embossed into top of can: ''011006 413N74 1P''
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal International Trading Inc, Brooklyn, NY, by press release on January 30, 2007.
Manufacturer: Ch. P. Lipina L.A, Kaliningrad, Russia. Firm initiated recall is complete.
REASON
The product is a processed uneviscerated fish based on sampling & analysis by New York State Department of Agriculture and Markets. This poses a health risk if consumed as it may contain Clostridium botulinum spores which can cause botulism.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
Product is an Oatmeal Cookie (label does not state product to be an Oatmeal Cookie). Label includes “Down Unders' nummy nutrition Mobile Meal egg-free. Product is packaged in 7 oz and 12 oz clear plastic cellophane wrap with an adhesive label affixed to packaging. Cookies are sold individually; fifty (50) cookies are placed in a box for delivery to consignees, Recall # F-261-7
CODE
No codes used on product
RECALLING FIRM/MANUFACTURER
Cuisine Med. Catering, Port Townsend, WA, by telephone on March 26, 2007 and visit on March 27, 2007. Firm initiated recall is complete.
REASON
The product lists whey as an ingredient but does not list milk as the source of the whey as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
VOLUME OF PRODUCT IN COMMERCE
7 oz. – 50 cookies; 12 oz. – 541 cookies
DISTRIBUTION
WA

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PRODUCT
Icapeb Rellenos Caramelos Surtti Frutas, Weight 450G/ 15/9 oz. UPC 7 861044 600754, Recall # F-262-7
CODE
No codes used on product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Family Food Distributor, Inc, Kearny, NJ, by telephone beginning on November 15, 2006.
Manufacturer: Icapeb, Quito, Ecuador. Firm initiated recall is complete.
REASON
Candies contain undeclared and possibly uncertified colors. Analysis of the product by the New York State Department of Agriculture and Markets found tartrazine (certifiable as FD&C Yellow No. 5), Sunset Yellow FCF (certifiable as FD&C Yellow No. 6), Brilliant Blue FCF (certifiable as FD&C Blue No. 1) and Allura Red AC (certifiable as FD&C Red No. 40).
VOLUME OF PRODUCT IN COMMERCE
20 cases of 24 x 15.9 oz. bags
DISTRIBUTION
NJ, NY, CT, NC, and OH

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PRODUCT
Sweet Dairy Whey (Edible Grade) Product Code: 7012, A Derivative of Milk, Plant 49-66, unit size 50 pound paper bags lined with polyethylene liner, stored under ambient conditions, Recall # F-263-7
CODE
SM06300, SM06307, SM06296
RECALLING FIRM/MANUFACTURER
Recalling Firm: Protient, Inc, Saint Paul, MN, by letters on November 18, 2006 and November 21, 2006.
Manufacturer: Utah Proteins LLC, Smithfield, UT. Firm initiated recall is ongoing.
REASON
Sweet Dairy Whey Powder may be contaminated with Salmonella. The product was used as an ingredient in foods that were further pasteurized.
VOLUME OF PRODUCT IN COMMERCE
97,500 pounds
DISTRIBUTION
NC, MO, and UT

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
Driscoll's brand fresh Strawberries in 1-lb clamshell containers (8 per case), 4-lb clamshell containers (2 per case), and 1 pint clamshell containers (12 per case). Recall # F-264-7
CODE
Lot # 0101770717
RECALLING FIRM/MANUFACTURER
Recalling Firm: Driscoll Strawberry Association, Watsonville, CA, by d-mail and telephone beginning on July 19, 2006.
Manufacturer: Royal Oaks Farms Ranch, Watsonville, CA. Firm initiated recall is complete.
REASON
The product has been found to contain 2 .65 ppm of Methomyl (lannate) pesticide. The EPA tolerance for this pesticide in strawberries is 2 ppm.
VOLUME OF PRODUCT IN COMMERCE
3,014 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

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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

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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

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) Children's Mucinex Expectorant (Guaifenesin, USP, 100mg/5mL), Grape Flavor Liquid,
    4 fl oz. (118mL) bottle, NDC 63824-173-64, Recall # D-797-2007;
b) Children's Mucinex Cough (Guaifenesin, USP 100mg/5mL and Dextromethorphan
    HBr 5mg/5mL), Cherry Flavor Liquid, 4 fl oz. (118mL), Expectorant and Cough
    Suppresent, NDC 63824-174-64, Recall # D-798-2007
CODE
a) Lot #605010, 605011, 605012, 606001, 606002, 606003, 606004, 606005,
    606006, 606007, 606008, 606009, 606010, 606011, 606012, 606014,
    606015, 606016, 606017, 606018, 606019, 606020, 608004, 608005,
    608006, 608007, 608008, 608009, 608010, 608031, 608032, 609001,
    609002, 609003, 609004, 609005, 609006, 609023, 609024, 609025,
    609026, 609027, 609028, 609029, 609030, 609031, 609032, 609033,
    609034, 609035, 610023, 610024, 610025, 610026, 610027, 610028,
    610029, 610030, 610032;
b) Lot #605007, 605008, 605009, 605021, 605022, 605023, 605024, 605025,
    605026, 605027, 605028, 605029, 607001, 607002, 607003, 607004,
    607005, 607006, 607007, 607008, 607009, 607010, 607011, 608011,
    608012, 608013, 608014, 608015, 608016, 608017, 608018, 608019,
    608020, 608021, 608022, 608028, 609007, 609008, 609009, 609010,
    609011, 609012, 609013, 609014, 609015, 609016, 609017, 609018,
    609019, 609020, 609021, 609022, 610003, 610004, 610005, 610006,
    610007, 610008, 610009, 610010, 610011, 610012, 610013, 610014,
    610015, 610016, 610017, 610018, 610019
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adams Respiratory Therapeutics, Inc, Fort Worth, TX, by letter on April 2, 2007.
Manufacturer: QPharma, LLC, Lawrenceville, NJ. Firm initiated recall is ongoing.
REASON
Misbranded; calibrated dosage dispensing cup may be confusing to consumers as measurements are shown in units of teaspoon and tablespoon while dosages are all listed in teaspoons
VOLUME OF PRODUCT IN COMMERCE
2,102,856 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1251-07
CODE
Unit: 041FV66018
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on March 11, 2006 and by letter dated March 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069,
    CT Scanner System, Recall # Z-0802-2007;
b) GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093,
    CT Scanner system, Recall # Z-0803-2007;
c) GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3,
    2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems,
    Recall # Z-0804-2007;
d) GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6,
    CT Scanner systems, Recall # Z-0805-2007;
e) GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3,
    Recall # Z-0806-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, LLC, Waukesha, WI, by letter dated December 4, 2006 beginning December 21, 2006. Firm initiated recall is ongoing.
REASON
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
1,817 devices
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122, Recall # Z-0810-2007
CODE
Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 19, 2007.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
VOLUME OF PRODUCT IN COMMERCE
14,503 systems
DISTRIBUTION
Nationwide

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PRODUCT
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer, Recall # Z-0812-2007
CODE
All units with the last 4 digits of the serial number under 3450. Serial numbers 5050012 6060290 6070319 6070346 6090389 6090416 6090417 6090418 6100419 7010600 7010601 7010602 7010603 7010604 7010605 7010606 7010607 7010608 7010609 7010611 7010612 7020648 7020649 7020650 7020651 7020652 7020653 7020654 7020655 7020656 7020683 7020684 7020685 7020686 7020687 7030745 7030746 7030747 7030748 7030749 7030751 7030752 7040808 7040809 7040810 7040811 7040812 7040813 7040814 7040815 7040816 7040817 7050834 7050835 7050836 7050837 7050838 7050871 7050872 7050873 7050874 7050875 7050876 7050877 7050878 7050879 7060931 7060932 7060933 7060935 7060936 7060937 7060938 7060939 7060940 7091037 7091038 7091039 7091040 7091041 7091060 7091079 7091080 7091081 7121199 7121200 7121201 7121202 7121203 8011222 8011223 8011224 8011225 8011226 8011228 8011229 8011230 8011231 8021232 8021233 8021234 8021235 8021236 8021237 8021238 8021239 8021240 8021241 8021242 8021243 8021244 8021245 8021246 8021247 8021248 8021249 8021250 8021251 8031259 8031260 8031261 8031262 8031263 8031264 8031265 8031269 8031286 8031287 8031288 8031289 8031290 8041304 8041305 8041306 8041307 8041308 8041309 8041310 8041312 8041313 8041314 8041315 8041316 8041317 8041318 8061357 8061358 8071387 8071388 8071389 8071390 8071391 8071392 8071393 8071394 9011495 9011496 9011497 9011498 9011499 9011500 9011501 9021521 9021524 9021525 9021526 9021528 9021529 9021530 9021531 9021532 9021537 9021538 9021539 9021540 9031557 9031558 9031559 9041594 9041595 9041596 9041597 9041598 9041599 9051600 9051601 9051602 9051603 9051604 9061645 9061646 9061647 9061648 9061659 9061660 9061661 9061662 9061663 9071689 9071690 9071691 9071693 9071694 9071695 9071696 9071700 9081714 9081715 9081729 9081730 9081731 9081736 9081737 9091739 9091741 9091768 9091769 9091770 9091774 9091775 9091776 9091777 9091778 9091779 9091783 9091784 9091785 9091786 9091787 9101842 9101843 9101844 9101845 9101846 9101847 9101848 9101856 9111858 9111861 9111862 9111863 9111864 9111865 9111866 9111867 9111868 9111874 9111876 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1092862 1102869 1102871 1102873 1102874 1102875 1102876 1102877 1102895 1102911 1112927 1112949 1112950 1112951 1112952 1112953 1112954 1112955 1112956 1112957 1112958 1112959 1112960 1112961 1112962 1123008 1123009 1123011 1123013 1123014 1123015 1123016 2013050 2013051 2013052 2023108 2023109 2023110 2023111 2023112 2023113 2023114 2023115 2023116 2023117 2023118 2023121 2023122 2023123 2023124 2023125 2023126 2023127 2023128 2023129 2023130 2023131 2023132 2023133 2023134 2023151 2023152 2023153 2023188 2023189 2023190 2023191 2023192 2033193 2033194 2033195 2033196 2033197 2033198 2033199 2033200 2033201 2033202 2033203 2043224 2043225 2043226 2043227 2043228 2043229 2043230 2043231 2043232 2043233 2043234 2043237 2043238 2043239 2043240 2043241 2043242 2043243 2043244 2043245 2043251 2043252 2043253 2043254 2043255 2043256 2043257 2043258 2043259 2043260 2043266 2043268 2043269 2043271 2043272 2043288 2043289 2043291 2043292 2043293 2043295 2043296 2043297 2053299 2053300 2053301 2053302 2053303 2053304 2053305 2053346 2053348 2053349 2053350 2053351 2053352 2053353 2053354 2053355 2053356 2053357 2053358 2053359 2053360 2053361 2053362 2063364 2063365 2063366 2063367 2063368 2073397 2073398 2073399 2073400 2073401 2073402 2073404 2073405 2073406 2073418 2073419 2073420 2073421 2073422 2073423 2073424 2073425 2073446 2073447 2073448 2073449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by representative visit beginning on January 18, 2007.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
REASON
Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
VOLUME OF PRODUCT IN COMMERCE
693 units
DISTRIBUTION
Nationwide

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PRODUCT
BacT/VIEW® Software, all versions. in vitro diagnostic database software, Recall # Z-0814-2007
CODE
Software Version C.30a -22105-68, Update Disk; 22105-69 Install Disk
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc, Durham, NC, by customer notification on December 19, 2006. Firm initiated recall is ongoing.
REASON
BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.
VOLUME OF PRODUCT IN COMMERCE
1233 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System, Recall # Z-0815-2007
CODE
00000249264MR3, 00000257756MR7, 00000255196MR8, 00000246630MR8, 00000259107MR1, 00000248178MR6, 00000257451MR5, 00000256200MR7, 00000260871MR9, 00000252451MR0, 00000259108MR9, 00000254480MR7, 00000254482MR3, 00000256198MR3, 00000249263MR5, 00000250755MR6, 00000251090MR7, 00000GE0131001, 00000GE0213040, 00000254375MR9, 00000GE0205028, 00000GE0210034, 00000227995MR8, 00000GE0212037, 00000GE0226049, 00000GE0410083, 00000260871MR9, 00000GE0234057, 00000GE0123041, 00000GE0302068
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by visit beginning June, 2006. Firm initiated recall is ongoing.
REASON
To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging, Recall # Z-0816-2007
CODE
Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188
RECALLING FIRM/MANUFACTURER
Recalling Firm: Instrumentarium Dental, Inc, Milwaukee, WI, by letter dated April 28, 2006.
Manufacturer: Soredex Palodex Group Oy, Tuusula, Finland. Firm initiated recall is ongoing.
REASON
There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36, Recall # Z-0811-2007
CODE
Lot numbers: 593025-5, 593027-5, 598408-5, 593028-5, 599866-5 and 593029-5
RECALLING FIRM/MANUFACTURER
Biomet 3i, Palm Beach Gardens, FL, by telephone and letter on April 25, 2007. Firm initiated recall is ongoing.
REASON
The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
VOLUME OF PRODUCT IN COMMERCE
362 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR MAY 23, 2007

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