January 15, 2003
03-03
_____________________________
PRODUCT
3.5 oz. Snack Carrot Cake under the Aunt Hannah, Mrs. Freshley, Blue Ribbon and Blue Bird labels.
Recall # F-147-3.
CODE
All individual products coded with "best if used by" date
through August 4, that includes Production Codes -
0205 0066
0205 0086
0205 0136
0205 0146
0205 0206
0205 0216
0205 0276
0205 0286.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mrs. Smith's Bakeries, LLC., Suwanee, GA, by visit and letter beginning July 3, 2002.
Manufacturer: Mrs. Smith's Bakery of Crossville, LLC Crossville, TN. Firm initiated recall is complete.
REASON
Undeclared Whey in Snack Carrot Cake Bars.
VOLUME OF PRODUCT IN COMMERCE
24,201 trays/48 cakes per tray.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
"Mocha Java Jump" Cookies packaged in clear cellophane bag reading: "100% NATURAL MONTANA Moon***Net Weight 4 oz." White stick on label on back of package reads: "MOCHA JAVA JUMP ingredients: ***white chocolate***" The cello wrapped cookies are packed in a plain white display box that contains 15 cookies. Recall # F-148-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Montana Moon, Inc., Billings, MT, by letter dated October 22, 2002. FDA initiated recall is complete.
REASON
The product contained undeclared non-fat dry milk.
VOLUME OF PRODUCT IN COMMERCE
2,910 cookies.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
CHINESE NEW YEAR CAKE, Net Wt. 27 oz., packaged in vacuum-packed flexible plastic containers. Recall # F-126-3.
CODE
Barcode # 66630 22888.
RECALLING FIRM/MANUFACTURER
Water Lilies Food, Inc., Brooklyn, NY, by telephone on February 5, 2002. State initiated recall is complete.
REASON
Product is a low-acid food that may have been prepared, packed, or held under conditions whereby it may have been rendered injurious to health (manufacture had not registered or filed scheduled process information).
VOLUME OF PRODUCT IN COMMERCE
Approx. 300 - 27 oz. Units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Three differently flavored frozen bars: strawberry, pecan and lemon. Each bar is 5 fl. oz.
a) Strawberrry: Product labeled in part: "LA PRINCESA
STRAWBERRY ICE CREAM BAR NET WT. 5OZ***
Recall # F-129-3;
b) Pecan: Product labeled in part: "LA PRINCESA PECAN ICE
CREAM BAR NET WT. 5OZ*** Recall # F-130-3;
c) Lemon: Product labeled in part: "LA PRINCESA LEMON ICE
FRUIT BAR NET WT. 5OZ*** Recall # F-131-3.
CODE
The recalled products do not bear manufacturing codes. All products remaining on the market and in-house were relabeled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: La Princesa, Dallas, TX, by visit beginning June 28, 2002.
Manufacturer: Paleteria La Princesa, Plant City, FL. Firm initiated recall is complete.
REASON
Products contain undeclared color, FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
a) 5200 (strawberry);
b) 5600 (pecan);
c) 5780 (lemon).
DISTRIBUTION
FL.
_____________________________
PRODUCT
Two different donut mixes, both sold in 50lb bags:
a) Labeled in part: "PARADISE PRODUCTS ORIGINAL YEAST
RAISE MIX*** Recall # F-132-3.
b) Labeled in part: "OMNI PRODUCTS Cake Donut Mix***
Recall # F-133-3.
CODE
Date codes reflecting dates between 12/13/01 and 1/15/02. Example of code: 1162 = 1/16/02.
RECALLING FIRM/MANUFACTURER
Omni Flour Distriburing, Inc. aka Paradise Donut, Catoosa, OK, by visit/letter on/about January 16, 2002. Firm initiated recall is complete.
REASON
The donut mixes were manufactured using flour recalled by ADM Milling, Overland Park, KS due to Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
a) 740 yeast 50 lb bags;
b) 91 cake 50lb bags.
DISTRIBUTION
OK, MO and AR.
_____________________________
PRODUCT
a) Albert's Original Poppy Seed Dressing packaged in 8-,
16-, and 24-oz. round bottles and flask (banjo-style)
bottles. The round bottles and the 8-oz. flask bottles
are packed 12 bottles per case. The 16-oz. and 24-oz.
flask bottles are shipped 6 bottles per case. Recall #
F-136-3;
b) Albert's Lite Classic Poppy Seed Dressing packaged in
16-oz. round bottles and 8-oz. and 16-oz. flask (banjo
-style) bottles. The 16-oz. round bottles and the 8-oz.
flask bottles are packed 12 bottles per case. The 16
-oz. flasks are packed 6 bottles per case.
Recall # F-137-3.
CODE
a) 092302C, 090602C, 092802A, 092802B, 092802C, 092802D,
100702A, 100702B, 100702C, 100702G, 110402E, 110402F, 092502A, 092502B, 092502C, and 092502D;
All codes of 8-oz, 16-oz, and 24-oz. flask (banjo style)
Bottles.
b) 092802F, 092802E, 100702D, 100702E, and 100702F
All codes of 8-oz, and 16-oz. flask (banjo style)
bottles.
RECALLING FIRM/MANUFACTURER
Ott Food Products, LLC Carthage, MO, by telephone on March 14, 2002 and letters March 18, 2002. FDA initiated recall is ongoing.
REASON
The products contained undeclared FD&C Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
KS, NE, OK, MO, IL, UT, IA, and SD.
_____________________________
PRODUCT
Ceramicware - Vintage Violet Collection.
a) Item 2007 - 9" Teapot. Recall # F-141-3;
b) Item 20070 - 4.5" Mug. Recall # F-142-3;
c) Item 20071 - 8.5" Pitcher. Recall # F-143-3;
d) Item 20078 - 8.5" Plate. Recall # F-144-3;
e) Item 20079 - 10.5" Plate. Recall # F-145-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pacific Rim Import Corporation, Seattle, WA, by letters on March 18, 2002. FDA initiated recall is complete.
REASON
The products contain elevated amounts of leachable lead.
VOLUME OF PRODUCT IN COMMERCE
2344 pieces distributed by firm.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
"YOYO" cookies. Recall # F-127-3.
Ingredients: Wheat, Flour B.B.S., Sugar, Water, Salt, Eggs, Cinnamon, Milk, Guava, Egg Shade No. 5, Vanilla, Baking Powder.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Oscar & John Molina DBA: A & D Bakery Co., Brooklyn, NY, by visit on April 3, 2002. State initiated recall is complete.
REASON
The product contained undeclared FD&C Red No. 3.
VOLUME OF PRODUCT IN COMMERCE
50 - 12 oz. Units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Bareman's Distilled Water in 1-gallon containers.
Recall # F-134-3.
CODE
Lot: Nov 05.
RECALLING FIRM/MANUFACTURER
Bareman Dairy, Inc., Holland, MI, by letter dated July 17, 2002. State initiated recall is complete.
REASON
Water has an off-odor/taste and cloudy appearance.
VOLUME OF PRODUCT IN COMMERCE
3,557 gallons.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) Albert's Original Steak House Dressing packaged in
16-oz. round bottles, 12 bottles per case.
Recall # F-138-3;
b) Ott's Albert's Original Frontier Ranch Dressing
packaged in 1 gal. jugs, 4 jugs per case.
Recall # F-139-3;
c) 1) Joe Joe's Italian Eatery Italian Salad Dressing and
2) Ott's/Albert's Italian Chef Salad Dressing packaged
in 1 gal. jugs, 4 jugs percase. Recall # F-140-3.
CODE
a) Code 092202B.
b) Codes: 081802, 102002, and 110602.
c) 1) Codes: 101902; 110402; 111102;
2) Codes: 101902; 110402; 111102.
RECALLING FIRM/MANUFACTURER
Ott Food Products, LLC Carthage, MO, by telephone on March 14, 2002 and letters March 18, 2002. FDA initiated recall is ongoing.
REASON
Steak House and Frontier Ranch Dressings contain undeclared monosodium glutamate. Italian Salad Dressings are labeled as containing hydrolyzed vegetable protein but do not list the source of the protein (soy).
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
KS, NE, OK, MO, IL, UT, IA, and SD.
PRODUCT
a) Garamycin Ophthalmic Ointment, USP (Gentamicin Sulfate)
0.3%, 3.5g tube, Rx only. Recall # D-069-3;
b) Celestone Phosphate Injection, USP(Betamethasone sodium
phosphate) 3 mg/mL, 5mL Multiple-Dose Vial, Rx only,
NDC-0085-0879-05. Recall # D-070-3;
c) Solganal Injectable Suspension , USP(Aurothioglucose),
500 mg, 50 mg/mL, 10 mL Multiple-Dose Vial, Rx only,
NDC-0085-0460-03. Recall # D-071-3;
d) Trilafon Injection, USP (Perphenazine), 5 mg, 1 mL
Ampule, NDC-0085-0012-04, Rx only. Recall # D-072-3;
e) Sterile Diluent (Bacteriostatic Water for Injection with
benzyl alcohol 0.945% w/v), 1 mL, NDC-0009-0780-46, Rx
only. Recall # D-073-3;
f) Bacteriostatic Water for Injection, USP., 2 mL syringe.
Recall # D-074-3.
CODE
a) All lots within expiry: 0-HJ-1, March 2003; 0-HG-2,
March 2003.
b) All lots within expiry: 0-AKP-3, August 2003; 0-AKP-2,
June 2003; 0-AKP-1, May 2003. 0-AKP-4, September 2003.
c) All lots within expiry: 0-WS-4, November 2002; 0-WS-5,
December 2002; 1-WS-1, March 2003.
d) All lots within expiry: 1-AEC-1, April 2004; 1-AEC-2,
April 2004; 9-AEC-9, November 2002.
e) All lots within expiry: 0-BEX-501, Mar-21-2003; 0-BEX-
502, Mar-25-2003; 0-BEX-503, Apr-02-2003; 0-BEX-504,
Apr-26-2003; 0-BEX-505, Jun-27-2003; 0-BEX-506, Jul-12-
2003; 0-BEX-507, Jul-12-2003; 0-BEX-508, Nov-18-2003;
0-BEX-509, Dec-01-2003; 0-BEX-510, Dec-27-2003; 1-BEX-
501, Feb-11-2004; 1-BEX-502, Feb-12-2004; 1-BEX-503,
Feb-22-2004; 1-BEX-505, Mar-22-2004; 1-BEX-506, Mar-29-
2004; 1-BEX-507, May-28-2004; 1-BEX-508, May-29-2004;
1-BEX-509, May-30-2004; 1-BEX-511, Aug-15-2004; 1-BEX-
512, Aug-20-2004; 1-BEX-513, Aug-27-2004; 1-BEX-514,
Aug-30-2004; 1-BEX-515, Oct-29-2004; 1-BEX-517, Nov-14-
2004.
f) All lots within expiry: 1-BEX-701, Mar-2003; 1-BEX-702,
Dec-2003; 2-BEX-701, Jan-14-2004.
RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ, by letter dated November 8, 2002. Firm initiated
recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
4,047,706 units.
DISTRIBUTION
Nationwide and Caribbean islands: Bahamas, Curacao, Trinidad, Jamaica, St. Kitts
and Aruba.
****CORRECTION****
The expiration date for the codes in Recall D-096/D-097-3 should be 7/03 not 7/04.
_____________________________
PRODUCT
a) Nabumetone Tablets, 500 mg, 100 count bottles, Rx only,
NDC 0185-0145-01. Recall # D-065-3;
b) Nabumetone Tablets, 750 mg, 100 count bottles, Rx only,
NDC 0185-0146-01. Recall # D-066-3.
CODE
a) and b) Lot 021159, expiration date 10/2004.
RECALLING FIRM/MANUFACTURER
Eon Labs Manufacturing Inc., Laurelton, NY, by letter and fax on November 13, 2002. Firm initiated recall is ongoing.
REASON
Mislabeling - some bottles labeled to contain Nabumetone 750 mg tablets actually contain Nabumetone 500 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1533 bottles total lot.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Premphase Tablets, (conjugated estrogens 0.625mg and
medroxyprogesterone 5mg) dial dispenser containing 28
tablets, Rx only. Recall # D-067-3.
b) Premarin Tablets (conjugated estrogens) 0.625 mg, Rx
only, unit dose packages of 100 (NDC 0046-0867-99),
bottles of 100 (NDC 0046-0867-81) and bottles of 5000
(NDC 0046-0867-95), Recall # D-068-3.
CODE
a) 9001385, Exp. 2/03; 9001386, Exp. 2/03
b) 100''s - lot #9001216, exp 5/03 5000''s - lot #9000986,
exp 5/05 unit dose 100''s - lot #.
RECALLING FIRM/MANUFACTURER
Robins, A.H./Division of American Home Products, Richmond, VA, by letter issued November 18, 2002, via certified mail. Firm initiated recall is ongoing.
REASON
Dissolution; failure to meet specifications at the 24 month/2-hour timepoint.
VOLUME OF PRODUCT IN COMMERCE
239,896 various size dispensers.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Pulmicort Turbuhaler (budesonide inhalation powder) 200mcg, 200 Metered Doses, Rx only, Professional Sample. Recall # D-075-3.
CODE
Lot Number: DA1625 Exp. Date: July 2003.
RECALLING FIRM/MANUFACTURER
Astra Zeneca Pharmaceuticals LP, Wilmington, DE, by letter to notify physicians, 11/18/02. Firm initiated recall is ongoing.
REASON
Fine particle size out of specification; patient may not receive full dose to lungs
VOLUME OF PRODUCT IN COMMERCE
23232 units (50 each).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Recall # Z-0342-3;
CODE
Lot number: 1170119, Expiration: 2007/10, Prescription: base curve 8.9, diameter 13.8, power -1.50.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on November 12, 2002 with attached Business Reply Card form. Firm initiated recall is ongoing.
REASON
Lenses were labeled with the wrong prescription.
VOLUME OF PRODUCT IN COMMERCE
559 vials.
DISTRIBUTION
CA, GA, IL, MN, NJ, TX, VA and Internationally.
_____________________________
PRODUCT
Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case. Recall # Z-0346-3.
CODE
Lot numbers 01H0161 through 01H2668.
RECALLING FIRM/MANUFACTURER
SSL Americas Inc., Norcross, GA, by telephone and letter November 25, 2002. Firm initiated recall is ongoing.
REASON
Sulfur particles on the surface of gloves.
VOLUME OF PRODUCT IN COMMERCE
173,310 pairs
DISTRIBUTION
Nationwide and Canada, Venezuela and British Colombia.
_____________________________
PRODUCT
a) SureStep 50 Test Strips, For the measurement of glucose
in whole blood, Two bottles of 25 Test Srips, LIFESCAN.
Recall # Z-0398-3;
b) Genuine One Touch Glucose 50 Test Strips, For the
quantitative measure of glucose in whole blood, For Sale
Outside of the USA and Canada. Product is packed two
vials of 25 strips per vial. Recall # Z-0399-3;
CODE
a) Lot: E-169380A, Exp: 2003-01;
b) Lot# 1666680A Exp. 2003-11.
RECALLING FIRM/MANUFACTURER
River City Drug, Marietta, GA by letters on/about October 8, 2002. Firm initiated recall is ongoing.
REASON
Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
a) 576 units (Sure Step);
b) 2790 units (Genuine One Touch).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Ohmeda Medical Giraffe(tm) Omnibeds; and Ohmeda Medical Giraffe(tm) Incubators. Recall # Z-409-3.
CODE
For corrections due to unintended movement of the Elevating Base the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF**** and HDHE*****, where "*****" refers to 5 digit numbers less than 54000.
For corrections of the leakage current defect in the devices, the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF***** and HDHE*****, where "*****" refers to 5 digit numbers less than 53000.
For corrections of the battery defect in the devices, the Giraffe OmniBeds and Giraffe Incubators are each identified with a unique S/N beginning with HDGD*****, HDGE*****, HDGF*****, HDHF***** and HDHE*****, where "*****" refers to 5 digit numbers less than 52000.
RECALLING FIRM/MANUFACTURER
Ohmeda Medical, Laurel, MD, by letter on October 21, 2002. Firm initiated recall is ongoing.
REASON
Electrical defects in neonatal incubators may lead to unintended movement.
VOLUME OF PRODUCT IN COMMERCE
1364 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Side Fire Laser Fibers, Models;
a) DBLF-60SF;
b) HBLF-60SF.
Recall # Z-0411-3.
CODE
a) lot numbers LP-260, LP-262, LP-266, and LP-267;
b) lot numbers LP-258, LP-260, LP-263, LP-265 and LP-271.
RECALLING FIRM/MANUFACTURER
Laser Peripherals, LLC., Golden Valley, MN, by telephone on October 15, 2002. Firm initiated recall is ongoing.
REASON
The laser fibers were manufactured with an expired epoxy sealant which could result in degradation and misdirection of the laser beam.
VOLUME OF PRODUCT IN COMMERCE
159 laser fibers.
DISTRIBUTION
Nationwide, Canada and Japan.
_____________________________
PRODUCT
Contigen Bard Collagen Implant. The product is one syringe filled with Contigen. Description: Contigen Bard collagen implant is a sterile, nonpyrogenic device composed of highly purified bovine dermal collagen. Recall # Z-0344-3.
CODE
Product Code 651005, Lot No.: 03GM2009, Exp.: 04/12.
RECALLING FIRM/MANUFACTURER
C.R. Bard, Inc., Urological Division, Covington, GA, by letters on November 4, 2002. Firm initiated recall is ongoing.
REASON
Contigen Bard Collagen Syringe cartons have incorrect expiration dates.
VOLUME OF PRODUCT IN COMMERCE
306 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
EXPO 32 Software. Recall # Z-0407-3.
CODE
Versions 1.0, 1.1B, and 1.2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing.
REASON
Software contains errors that might affect Cytometry instruments.
VOLUME OF PRODUCT IN COMMERCE
33.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Cryo-Tip T-1910 Exo-Endocervical, Part Number 90501 (as labeled) for use with the Circon Cryomedics MT-700 Cryosurgical System. Recall # Z-412-3.
CODE
Lot TMDFC.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ACMI Corporation, Racine, WI, by telephone on June 19, 2002.
Manufacturer: Circon Acmi, Norwalk, OH. Firm initiated recall is ongoing.
REASON
Derm Bevel Cryo-Tips, Part Number 90512, were mislabeled as Exo-Endocervical Cryo-Tips, Part Number 90501.
VOLUME OF PRODUCT IN COMMERCE
7 Cryo-tips.
DISTRIBUTION
CA and TX.
END OF ENFORCEMENT REPORT FOR JANUARY 15, 2003
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