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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October 12, 2005
05-41

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
EL PURO: Queso Seco Cheese, Sold under various labels, the product tested had the El PURO brand. The size of the product varies from 12 oz. to 40 lb., Recall # F-001-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Latin Food Group Inc., Medley, FL, by letter and press release on August 22, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes based on the Florida Department of Agriculture and Consumer Services’ analysis.
VOLUME OF PRODUCT IN COMMERCE
50-40 lb. blocks
DISTRIBUTION
NC and FL

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
Sweet Ease- The Sucrose Solution. The product is a 24% sucrose and water solution. The product is aseptically packaged in an ll ml cup with a peel off lid that is suitable for dipping a pacifier or for administration via a dropper. It is shipped in cases containing 50 cups, Recall # F-675-5
CODE
Lot # 1365, Individual containers are coded as 2005/11/12-1N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Respironics, Inc., Murrysville, PA, by telephone and letters beginning on July 19, 2005.
Manufacturer: Kohler Mix Specialties, Newington, CT. Firm initiated recall is ongoing.
REASON
Potential risks of infection and other illnesses associated with the presence of mold contamination I a medical food product used for newborns and infants in the clinical setting.
VOLUME OF PRODUCT IN COMMERCE
6,394 cases
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
a) FIRST COLD PRESSED HERMES® brand EXTRA VIRGIN
   OLIVE OIL, Net Content 3 Liters (3 qts. 5.4
   fl oz), packed in metal cans. Product is labeled
   on side panel as “Product of Greece” and bears
   the Greek flag on front & back panels, OR
   “Packed in Italy L-97-05”. There are six --
   3 Liter metal cans per case. Recall # F-673-5;
b) HERMES® brand POMACE OLIVE OIL, Net Content
   3 Liters (3 qts. 5.4 fl oz), packed in metal
   cans. L 56-05 (on side panel). Product is
   labeled on other side panel as "100% GREEK
   OIL, Packed in Italy". There are six - 3
   Liter metal cans per case. Recall # F-674-5
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Krinos Foods, Inc., Long Island City, NY, by letters dated July 18, 2005 and July 28, 2005.
Manufacturer: Fabio Mataluni & Co., Montesarchio Bn, Italy and Oleificio Flli Amato, Partanna, Italy. Firm initiated recall is ongoing.
REASON
Products labeled as “olive oil” may consist primarily of soybean oil.
VOLUME OF PRODUCT IN COMMERCE
a) 1,231 cartons;
b) 10,268 cartons
DISTRIBUTION
Nationwide and Canada

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PRODUCT
a) Pacific Blue Lirate Asiatic (hard boiled)
   Clam Whole Cooked, 1 lb case.
   Recall # F-676-5;
b) Pacific Blue Granular Ark clam, 1 lb case,
   Recall # F-677-5;
c) Pacific Blue Lirate Asiatic (hard boiled)
   White Clam, 1 lb case, Recall # F-678-5
CODE
All Date Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pacific Blue Trading Co., LLC, East Hartford, CT, by letter dated August 10, 2005 and telephone.
Manufacturer: Phu Yen Seafood Corporation, Phu Yen, Vietnam. Firm initiated recall is complete.
REASON
Raw seafood products may be mislabeled as cooked.
VOLUME OF PRODUCT IN COMMERCE
Estimated 66 cases
DISTRIBUTION
MA. CT. RI, ME, NH, NY, PA, MD and VA

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PRODUCT
Traders Joe’s Eggplant Garlic Spread in glass jars. A traditional Bulgarian Recipe of Eggplant, Garlic & Ferreroni Peppers. Net Wt. 12 oz. (340g). Product of Bulgaria, Recall # F-679-5
CODE
Lot #’s: 43009 and 42909
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trader Joe’s, Needham, MA, by email on August 10, 2005 and August 12, 2005.
Manufacturer: Konex-Tiva Ltd, Sofia, Bulgaria. Firm initiated recall is complete.
REASON
The product contains filth.
VOLUME OF PRODUCT IN COMMERCE
123 cases
DISTRIBUTION
CT, DE, IN, MA, MD, NJ, NY, OH, PA and VA

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Prasco Laboratories T-Tanna DM Suspension, Antihistamine/Decongestant Antitussive, Cotton Candy Flavor, Rx Only, 16 fl. oz. (473 mL), NDC 66993-542-57, Recall # D-001-6
CODE
Batch # GB952
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Inc., Gainesville, GA, by letter on/about September 30, 2005. Firm initiated recall is ongoing.
REASON
Superpotent: Out of specification results.
VOLUME OF PRODUCT IN COMMERCE
1,593 bottles
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells, Recall # B-2425-5
CODE
Unit number: 2095651
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on January 30, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of plasma that was found to contain clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2426-5
CODE
Unit numbers: 2119199, 2103431, 2113323, 2123504, 2119399, 2119384, 2116396, 2109231, and 2124784
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on November 26, 2004. Firm initiated recall is complete.
REASON
Blood products exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
KY

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-2427-5;
b) Fresh Frozen Plasma, Recall # B-2428-5
CODE
a) Unit numbers: 2104644, 2088188, 2124335, and 2122776;
b) Unit number: 2114761
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on November 26, 2004. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY

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PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-2429-5
CODE
Unit number: 71J446534
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on July 13, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Source Plasma, Recall # B-2433-5
CODE
Unit number CP-110535
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Colton, CA, by facsimile on September 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not acceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-2434-5;
b) Fresh Frozen Plasma, Recall # B-2435-5
CODE
a) and b) Unit number 10757-0912
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, possibly collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

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PRODUCT
Prisma continuous renal replacement system. Model/Catalog Numbers: 018080100, 018080101, 018080001D, Recall # Z-1545-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Lakewood, CO, by press release and letter on August 16, 2005.
Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy. Firm initiated recall is ongoing.
REASON
Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss. Failure of the operator to adequately address the cause for an ‘Incorrect Weight Change Detected” alarm and choose to continue the procedure could resulting excessive ultrafiltration.
VOLUME OF PRODUCT IN COMMERCE
1,964 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System, Versions 1 and 2. Web Based Data Management System, no packaging. Recall #-Z-1594-05
CODE
Versions 1 and 2. Built 1041 and 1048. Product is a downloadable software package
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Medisense Products, Alameda, CA, by web postings and telephone on August 30, 2005. Firm initiated recall is ongoing.
REASON
Downloadable software obtained from the firm’s website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
VOLUME OF PRODUCT IN COMMERCE
N/A. Product is a downloadable software package.
DISTRIBUTION
Nationwide

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PRODUCT
OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2" stainless steel cannula with two 25g x 9/16" tip extensions. There are eight .25mm ports (four per tip). Recall # Z-1595-05
CODE
A. Product Specification 4036V Lot D1201AD Lot D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE Lot D0705Y Lot D0805A8 B. Product Specification 8065403604 Lot D0304S Lot D0405A Y Lot D05058H C. Product Specification MK-036V Lot D0305Y D. Product Specification 8-4036V-NS Lot D060488 Lot D0804T Lot D0904A Lot D1004AV Lot D12048X
RECALLING FIRM/MANUFACTURER
Oasis Medical, Inc., Glendora, CA, by fax and letter on August 24, 2005. Firm initiated recall is ongoing.
REASON
Foreign deposit present on the surface of the Vidaurri Lasik Flap Irrigators.
VOLUME OF PRODUCT IN COMMERCE
9,859 cannulas
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR OCTOBER 12, 2005

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