FDA Recall
Terminated
Historical recordClass II
Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
by Pharmatech LLC
- Reason
- CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Global Garlic, Inc.
- Product
- Ducal Apple Nectar, 5.3 oz cans.
- Reason
- Florida Department of Agriculture and Consumer Services surveillance sample tested positive for arsenic above 10 ppb.
- Published
- October 5, 2016
- Distribution
- FL, GA, IA, IL, NC, RI, TN, TX, VA, & WA…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Crofters 12 pound wheels, Six pound half wheels, and wedges…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Polkton Corners 12 pound wheels, Six pound half wheels, and…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Fait Fras 12 pound wheels, Six pound half wheels, and wedge…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Chili Cheese 12 pound wheels, Six pound half wheels, and we…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Lamont Cheddar 12 pound wheels, Six pound half wheels, and…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Edam 12 pound wheels, Six pound half wheels, and wedges of…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Leyden 12 pound wheels, Six pound half wheels, and wedges o…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Country Dill 12 pound wheels, Six pound half wheels, and we…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Onion n Garlic 12 pound wheels, Six pound half wheels, and…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grassfields Cheese, LLC
- Product
- Gouda 12 pound wheels, Six pound half wheels, and wedges of…
- Reason
- contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- Bounce Energy Ball Cashew & Pecan Vitality Lift, each loose…
- Reason
- Bounce Energy Ball Cashew & Pecan Vitality Lift is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- Australia -Cashew Cinnamon - Caf¿ Bounce, each bulk bag cont…
- Reason
- Cashew Cinnamon - Caf¿ Bounce is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bounce Life Style HQ
- Product
- US - Bounce Apple Cinnamon Protein Punch Energy Balls (old n…
- Reason
- Apple Cinnamon Protein Punch Energy Ball product is recalled because it has the potential to be contaminated with Listeria monocytogenes. This product contains sunflower kernels that were recalled by supplier SunOpta.
- Published
- October 5, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Faribault Foods, Inc
- Product
- No-Salt-Added Black Beans, 15 oz. (425 g), packaged under th…
- Reason
- Faribault Foods is recalling 15 oz.No-Salt-Added Black Beans due to potential presence of plastic and/or metal pieces.
- Published
- October 5, 2016
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass III
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
by Genzyme Corporation / Genzyme Biosurgery
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
by Lupin Limited
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration Date
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
by West-Ward Pharmaceuticals Corp.
- Reason
- Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
- Published
- September 28, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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