RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
1) Alfalfa Sprouts are packaged in plastic bag with various sizes 4 oz, 1 lb, and 5 lb. The products are distributed under brand name Evergreen Produce. The 5 lb. bag is distributed to two distributors with a white adhesive stick-on label and no UPC. The 1 lb. package has a UPC 8 38796 00108 2. The 4 oz. package has a UPC 8 38796 00103 7. The 1 lb. package is labeled in parts: "***Evergreen Produce***Alfalfa Sprouts***Locally Grown***Net wt. 16 oz. (1 lb.) 454g***Keep Refrigerated***Ingredients: Alfalfa Sprouts. The 4 oz. package is labeled in parts: "***Evergreen Produce***Alfalfa Sprouts***Locally Grown ***Net wt 4 oz. (1/4 lb.) 113g***Keep Refrigerated; Ingredients: Alfalfa Sprout. The 5 lb. bag is labeled in parts: "*** Packaged on***Best if Used by***Alfalfa 5#***". Recall # F-1517-2011;
2) Spicy Sprouts are packaged in plastic bag with various sizes 4 oz. and 1 lb. The 1 lb. bag is distributed to distributor with a white adhesive stick-on label and does not a UPC. The 4 oz. package has a UPC 8 38796 00102 0. The 4 oz. package is labeled in parts: "***Evergreen Produce***Spicy Sprouts***Locally Grown, Net Wt. 4 oz. (1/4 lb.) 113g***Keep Refrigerated***Ingredients: Radish, Clover & Alfalfa Sprouts. Recall # F-1518-2011
CODE
1) and 2) Expiration Dates from 06 22 through 07 14
RECALLING FIRM/MANUFACTURER
Evergreen Produce LLC, Moyie Springs, ID, by telephone and faxed letter on June 30, 2011, by press release on June 24, 2011 on June 27, 2011 and July 1, 2011. FDA initiated recall is ongoing.
REASON
Potential Salmonella Enteritidis contamination in Alfalfa Sprouts and Spicy Sprouts.
VOLUME OF PRODUCT IN COMMERCE
530 lbs. Alfalfa Sprouts; 840/4 oz. Pkg. of Alfalfa Sprouts; 20 lb. Spicy Sprouts and 480/4 oz Pkg of Spicy Sprouts
DISTRIBUTION
WA and ID
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PRODUCT
1) Cherry Pie, 8 inch, 23 oz, ready to eat, packaged in square white box with a see-through window on top. Sold exclusively at Whole Foods Market and with a white stick on label reading in part: "Cherry Pie 8" Filling (Red Cherries, ***Crust**Wheat Flout***" Sticker Also Includes a Pack Date and a Sell by Date. Recall # F-1573-2011;
2) Apple Pie, 8 inch, 23 oz, ready to eat, packaged in square white box with a see-through window on top. Sold exclusively at Whole Foods Market and with a white stick on label reading in part: "***Apple Pie 8" Filling: Apples, Water, Sugar***Crust: Unbleached Wheat Flour***". Sticker Also Includes a Pack Date and a Sell by Date. Recall # F-1574-2011;
3) Marionberry Pie, 8 inch, 23 oz, ready to eat, packaged in square white box with a see-through window on top. Sold exclusively at Whole Foods Market and with a white stick on label reading in part: "***Marionberry 8" Pie Marionberries, Sugar, ***Crust: Unbleached Wheat Flour***". Sticker Also Includes a Pack Date and a Sell by Date. Recall # F-1575-2011
CODE
1), 2) and 3) PACK DATES: JULY 1, 2011 - JULY 13, 2011. SELL BY DATES: JULY 6, 2011 - JULY 18, 2011
RECALLING FIRM/MANUFACTURER
Willamette Valley Fruit Company LLC, Salem, OR, by email on July 13, 2011 and by press release on July 14, 2011. Firm initiated recall is complete.
REASON
The Apple, Cherry, and Marionberry pies contain undeclared milk allergen (butter).
VOLUME OF PRODUCT IN COMMERCE
Approximately 1200 pies
DISTRIBUTION
CA, NV
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PRODUCT
Organic Spinach Flakes, 10 KG Net, Product of China, NOP Certified. Recall # F-1577-2011
CODE
Lot # SF11001; Lot # 37582
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by e-mail on July 8, 2011.
Manufacturer: Shandong Wonderland Organic Food Co., LTD, Linyi, China. Firm initiated recall is ongoing.
REASON
Product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
150 cartons ( 10 kg/ carton)
DISTRIBUTION
NV
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
1) Mama LaRosa, SOFO, Derby, and Flavor Peak Italian Style Dough Balls for use as pizza dough or bread sticks packaged in, plastic-lined corrugated cardboard boxes, containing between 12 and 72 varying weights of dough balls per package. Each package contains pre-printed brand labeling on the Box including product name, product code, quantity, product size, ingredients and manufacturing code. Recall # F-1578-2011;
2) SOFO Supreme I Italian Style Dough Balls for use as pizza dough or bread sticks packaged in, plastic-lined corrugated cardboard boxes, containing 96, 3.5 oz dough balls per package. Each package contains pre-printed brand labeling on the Box including product name, product code, quantity, product size, ingredients and manufacturing code. Product Code 18153-96037. Recall # F-1579-2011
CODE
1) Lot Numbers 113 01 11 through 203 12 11 for Product Codes: Mama LaRosa: 18153-36101, 18153-32111, 18153-30121, 18153-26131, 18153-24141, 18153-22161, 18153-24171, 18153-20181, 18153-18191, 18153-18201, 18153-16221, 18153-16231, 18153-14241, 18153-14261, 18153-12281, and 18153-12301, SOFO: 18153-36101, 18153-32111, 18153-30121, 18153-24141, 18153-22161, 18153-20181, 18153-18191, 18153-18201, 18153-16221, 18153-14241, 18153-14261, 18153-12281, 18153-12301, 18153-72051, 18153-60651, and 18153-44081, , Derby: 18153-60057, 18153-26137, 18153-20177, and 18153-36107, Flavor Peak:18153-36101, 18153-26131, 18153-22161, 18153-18191, 18153-18201, 18153-16221, 18153-14241, 18153-14261, 18153-72051, and 18153-44081;
2) Lot Numbers 113 01 11 through 203 12 11
RECALLING FIRM/MANUFACTURER
Mama LaRosa Foods, Inc., Taylor, MI, telephone beginning July 28, 2011 and by letters on July 29, 2011. Firm initiated recall is ongoing.
REASON
SOFO Supreme Italian Style Dough Balls contains wheat, not declared as the source of the flour and milk not declared as the source of whey on the product label.
VOLUME OF PRODUCT IN COMMERCE
70, 538 cases containing 1,265, 160 units
DISTRIBUTION
MI, IN, LA, FL, PA, OH
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
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PRODUCT
O.N.E. Coconut Water, packaged in 11.2 oz Tetra Pak cartons, 12 packages per case, UPC # 894991001104. Recall # F-1580-2011
CODE
Lot code 12E1004, and Sell-by date of May 1, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: One World Enterprises, LLC, Los Angeles, CA, by press release on March 11, 2011 and a letter on March 16, 2011.
Manufacturer: AMACOCO AGUA DE COCO DA AMAZONIA LTDA, Ananindeua, Brazil. Firm initiated recall is ongoing.
REASON
The recall was initiated because ONE World Enterprises, LLC has confirmed that O.N.E. Coconut Water, packaged in 11.2 oz Tetra Pak cartons may permit growth of mold due to the potential oxidation of the product.
VOLUME OF PRODUCT IN COMMERCE
11,272 units
DISTRIBUTION
OH, RI, NY, WA, CA, and IL
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
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