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U.S. Department of Health and Human Services

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Enforcement Report for June 9, 2004

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.


June 9, 2004
04-23

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Masagana Brand Sweet Coconut Gel (Nato de Coco) 12 oz.
glass bottle. Recall # F-242-4.
CODE
All products on the market at the time the recall were initiated.
RECALLING FIRM/MANUFACTURER
Phil-Am Trading, Jersey City, NJ, by press release on March 26, 2004, letters and telephone on March 27, 31, and April 1, 2004. New York State initiated recall is complete.
REASON
Produce contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
2,016 bottles.
DISTRIBUTION
NJ, NY, PA, FL, and DE.

_______________________________
PRODUCT
Ice Cream in cardboard cartons labeled as Lucerne chocolate
Ice Cream Half Gal. Recall # F-243-4.
CODE
Best Before JAN 10 05 53-38.
RECALLING FIRM/MANUFACTURER
Safeway, Inc., Pleasanton, CA, by press release and e-mail on April 27, 2004. Firm initiated recall is complete.
REASON
Produce contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
438 ? gallon containers.
DISTRIBUTION
AK, ID, OR, WA, and MT.

_______________________________
PRODUCT
SeaSpecialties Fresh Hand Packed Thin Sliced Smoked
Atlantic Salmon, Net Wt. 4 oz., 8 oz. and 16 oz. Recall #
F-245-4.
CODE
Aug 30, 2004.
RECALLING FIRM/MANUFACTURER
Florida Smoked Fish Co., Miami, FL, by letter and press release on March 15, 2004. Florida State initiated recall is complete.
REASON
A sample collected and analyzed by the Florida Dept. of Agriculture and Consumer Services on March 1, 2004 was positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
5,000 lbs.
DISTRIBUTION
FL, WI, OH, AL, IL, MO and CA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Stappj Bitter Non-Alcoholic Carbonated Apertif, 3.4 fl. Oz.
bottle. Recall # F-238-4.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Casa Imports, Inc., Utica, NY, by letter dated April 16, 2004. FDA initiated recall is complete.
REASON
The product contains undeclared color ? Allura Red AC, certifiable as FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
14 cases x 8/6-packs.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Collins Bros Gourmet Clam Chowder, 1 Gallon Boilable Plastic Bag. Recall # F-239-4.
CODE
All products produced prior to April 21, 2004.
RECALLING FIRM/MANUFACTURER
Collins Brothers Chowder Co., Nashua, NH, by visit on April 23, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
80/1 gallon units.
DISTRIBUTION
NH, and MA.

_______________________________
PRODUCT
Friendly?s ?Apple Pie a la Mode, Limited Edition? Ice Cream , Half-Gallon (1.89L), packaged in a Cardboard Container U.P.C. code #29839-00529. Recall # F-244-4.
CODE
Lot Code: ?25-26 WC5 SEP 22 04?, inkjet printed above the Nutrition Facts.
RECALLING FIRM/MANUFACTURER
Friendly Ice Cream Corp, Wilbraham, MA, by e-mail on November 20, 2003, and by fax/e-mail, letter and press release on November 21, 2003. Firm initiated recall is complete.
REASON
Product may contain foreign rubber material.
VOLUME OF PRODUCT IN COMMERCE
12,504 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Product is a carbonated soft drink product packaged in a 12
oz. aluminum can labeled as Sam?s Choice Mountain
Lightning, Item number 95 55570, packaged in 12 can packs.
Recall # F-240-4.
CODE
?Best Buy Date 102804 TA? and also ?101104 TA?.
RECALLING FIRM/MANUFACTURER
Cott Beverages, Tampa, FL, by telephone and e-mail on February 18, and 19, 2004. Firm initiated recall is complete.
REASON
The product contains potassium benzoate crystals.
VOLUME OF PRODUCT IN COMMERCE
117,500 - 12 packs.
DISTRIBUTION
GA, FL, and MS.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Eye Drops Artificial Tears, (Polyvinyl alcohol 0.5% and
Povidone 0.6%), 20 mL (.67 FL OZ), over-the-counter,
NDC 67234-009-01. Recall # D-175-4;
b) Eye Drops Allergy Relief, (Naphazoline hydrochloride
0.012% Glycerin 0.2%, Zinc Sulfate 0.25%), 20 mL (.67 LF
OZ) plastic bottles, over-the-counter, NDC 67234-011-01.
Recall # D-176-4;
c) Eye Drops, Extra Relief, (Naphazoline hydrochloride
0.012% Glycerin 0.2%, 20 mL (.67 FL OZ) plastic bottles,
over-the-counter, MADE IN THE USA, NDC 67234-010-01.
Recall # D-177-4;
d) No Drip Nasal Spray, (Oxymetazoline 0.05%), 20 mL (.67
FL OZ) plastic bottles, 12 Hour Pump Mist, over-the-
counter, Made in the USA, NDC 67234-012-01.
Recall # D-178-4.
CODE
a) Item No. 3100, All lot numbers and expiration dates;
b) Item No. 3101, All lot numbers and expiration dates;
c) Item No. 3102, All lot numbers and expiration dates;
d) All lot numbers and expiration dates.
RECALLING FIRM/MANUFACTURER
Natureplex Llc, Memphis, TN, by facsimile on March 1, 2004, and by press release on March 3, 2004. FDA initiated recall is ongoing.
REASON
Non sterile; product manufactured under non-sterile conditions.
VOLUME OF PRODUCT IN COMMERCE
485,925 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-1343-4.
CODE
Unit numbers: 0510314956, 0510314522, 0510314124, 0510313651, 0510313287, 0510312873, 0510312553, 0510312230, 0510311848, 0510311399, 0510310968, 0510303380, 0510303008, 0510301661, 0510301262, 0510300878, 0510300348, and 0510299501.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Nashville, TN, by facsimile on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that did not have the routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1409-4;
b) Cryoprecipitated AHF. Recall # B-1410-4.
CODE
a), and b) Unit 5628193.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on February 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1411-4.
CODE
Unit 5628193.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on February 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1424-4;
b) Red Blood Cells Leukocytes Reduced. Recall # B-1425-4;
c) Red Blood Cells Irradiated. Recall # B-1426-4;
d) Red Blood Cells Leukocytes Reduced Irradiated.
Recall # B-1427-4;
e) Platelets. Recall # B-1428-4;
f) Platelets Pheresis. Recall # B-1429-4;
g) Platelets Pheresis Leukocytes Reduced. Recall #B-1430-4;
h) Fresh Frozen Plasma. Recall # B-1431-4;
i) Plasma Frozen Cryoprecipitated Removed.
Recall # B-1432-4;
j) Cryoprecipitated AHF. Recall # B-1433-4;
k) Granulocytes. Recall # B-1434-4;
l) Recovered Plasma. Recall # B-1435-4.
CODE
Blood products, which were collected between May 2001 and March 2002, of the above types.
RECALLING FIRM/MANUFACTURER
Lifeshare, Inc., Elyia, OH, by letters beginning December 1 through December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7,690.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
STS-T Mobile X-Ray System. Recall # Z-0884-04.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Medstone International Inc., Aliso Viejo, CA, by letter and service representative visit beginning on May 21, 2004. Firm initiated recall is ongoing.
REASON
The identification and certification labels were inadequate or missing.
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Laser System, model CNI GLP-III green laser pointer. Use for industrial, scientific and research purposes. Recall # Z-0956-04.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Changchun New Industries Optoelectronics Tech, Co., Ltd., Changchun, China, by letter beginning on May 16, 2004. Firm initiated recall is ongoing.
REASON
The laser product was found to be noncompliant with the laser product report.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
WA, CA, and MN.

_______________________________
PRODUCT
Coulter AcT 5diff Autoloader (AL) Hematology Analyzer.
Recall # Z-0987-04.
CODE
All software versions (1.00 & 1.20).
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on or about April 20, 2004. Firm initiated recall is ongoing.
REASON
Software anomaly causes sample results to be not credible, reported as ?0? or left blank. The next sample will also be incorrectly reported for the same parameter.
VOLUME OF PRODUCT IN COMMERCE
71
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Power Heart AED G3 Automated External Defibrillator
IntelliSense (Lithium) Battery, Model 9142.
Recall # Z-0990-04;
b) FirstSave AED G3 Automated External Defibrillator
IntelliSense (Lithium) Battery, Model 9143.
Recall # Z-0991-04.
CODE
a) Lot numbers: 7848, 7849, 7850, 7853, 7854, 7855, 7857,
7858, 7859, 7860, 7861, 7863, 7866, 7867, 7868, 7870,
7871, 7872, and 7874;
b) Lot numbers: 7851, 7852, and 7856.
RECALLING FIRM/MANUFACTURER
Cardiac Science, Inc., Irvine, CA, by letter dated May 10, 2004. Firm initiated recall is ongoing.
REASON
Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
VOLUME OF PRODUCT IN COMMERCE
4,730 batteries.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) Compounding Brochure titled ?Nutrition Compounding
Simplified?, Lit #800415, print date January 2002; the
brochure is applicable to the Automix Plus High Speed
Compounder System, product 2M8075, the Automix High
Speed Compounder System, product 2M8077, the Automix 3+3
Compounder System, product 2M8286, the Automix 3+3
Compounder with Accusource Monitoring System, product
2M8287, the Micromix Compounder System, 1.0 mL, product
2M8290, and the Micromix Compounder System, 0.3 mL,
product 2M8290L; Recall # Z-0988-04;
b) Micromix Compounder Implementation Guide; this guide is
distributed by Professional Services as part of the
training classes for new Micromix Compounder customers.
Recall # Z-0989-04.
CODE
a) Lit #800415, print date January 2002 This brochure was
distributed individually and as part of the Baxter Info
Quick Card (on CD-Rom), versions Q4 2003 and Q2 2003;
b) Pages 60 and 61 of the guide.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated April 30, 2004. Firm initiated recall is ongoing.
REASON
The promotional material for the Automix/Accusource and
Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.
VOLUME OF PRODUCT IN COMMERCE
1,366 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials. Recall # Z-0992-04.
CODE
Lots MX249N and MX249H of ABX Diagnostics Minotrol 16 Controls, Normal and High; and Lots 040308ND and 040308HD of Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High.
RECALLING FIRM/MANUFACTURER
R & D Systems, Inc., Minneapolis, MN, by letters dated April 15, 2004. Firm initiated recall is ongoing.
REASON
Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing.
VOLUME OF PRODUCT IN COMMERCE
29,494 vials of the normal controls and
15,196 vials of the high controls.
DISTRIBUTION
CA, France, and Japan.

_______________________________
PRODUCT
Fuji Flash IIP and CR-IR346CL Consoles. Recall # Z-0993-04.
CODE
Versions A09-17 through A11-12.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated May 5, 2004. Firm initiated recall is ongoing.
REASON
Software: Incorrect measurement of objects within a CR image.
VOLUME OF PRODUCT IN COMMERCE
2,602 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035. Recall # Z-0994-04.
CODE
Lot Code: K589039; K658262; K658259; K74990; K766542.
RECALLING FIRM/MANUFACTURER
Howmedica Osteonics Corp., Mahwah, NJ, by letters on March 31, 2004. Firm initiated recall is ongoing.
REASON
Targeting device may become distorted upon repeated autoclaving.
VOLUME OF PRODUCT IN COMMERCE
32 devices.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, Sterile Vehicle 17 ml. to be used to constitute moxidectin microspheres, 10% w/w moxidectin microspheres, packed in 5-unit packs of 20-ml. moxidectin microsphere and vehicle vials, RX, NADA 141-189, NDC 0856-3670-20. Recall # V-130-4.
CODE
Lot 367158214, Exp. April 05, and Lot 367158215, Exp. June 05.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters on April 27, 2004. Firm initiated recall is ongoing.
REASON
Failing dissolution results for the moxidectin microspheres at the 6-month stability time point.
VOLUME OF PRODUCT IN COMMERCE
7,390/5-unit packs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Metacam (meloxicam) 1.5 mg/mL Oral Suspension, Non-steroidal anti-inflammatory drug for oral use in dogs only, packaged in 10-ml bottles, RX, NADA #141-213. Recall # V-131-4.
CODE
Lot # 113ZM71.
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Vetmedica Inc., MO, by letters dated March 3, and March 25, 2004. Firm initiated recall is complete.
REASON
A kilogram dosing syringe was packaged with the product rather than a dosing syringe calibrated in pounds.
VOLUME OF PRODUCT IN COMMERCE
65,890 packages.
DISTRIBUTION
TN, GA, and IA.

 

END OF ENFORCEMENT REPORT FOR JUNE 9, 2004

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