FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
KRAFT HEINZ FOODS COMPANY
- Product
- Weight Watchers Smart Ones, Chocolate Chip Cookie Dough Sund…
- Reason
- Possible contamination of product with Listeria monocytogenes.
- Published
- December 14, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Green Dirt Farm, LLC
- Product
- Green Dirt Farm "Dirt Lover" sheep's milk cheese packaged in…
- Reason
- Product is contaminated with Staphylococcus aureus exceeding action limit of 10,000 cfu/g.
- Published
- December 14, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Green Dirt Farm, LLC
- Product
- Green Dirt Farm "Ruby" blended milk cheese packaged in cases…
- Reason
- Product is contaminated with Staphylococcus aureus exceeding action limit of 10,000 cfu/g.
- Published
- December 14, 2016
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Taylor Farms Pacific Inc. (MacArthur Facility)
- Product
- Taylor Farms Veggie & Hummus Bistro Box: Baby Carrots, Hu…
- Reason
- Firm was notified by supplier that the hummus included in their vegetable and hummus trays has been recalled due to Listeria monocytogenes contamination.
- Published
- December 14, 2016
- Distribution
- US only - MO, TX, LA, NV, TN, NC, GA, AL…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Calbee North America, LLC
- Product
- HARVEST SNAPS, SNAPEA CRISPS, BLACK PEPPER FLAVORED GREEN PE…
- Reason
- One lot of black pepper flavored green pea crisps may contain wasabi ranch flavored green pea crisps which contain milk which is not declared on the black pepper flavored product.
- Published
- December 14, 2016
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Safecor Health, LLC
- Product
- Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-01…
- Reason
- Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate
- Published
- December 14, 2016
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SSI-GoPicnic LLC
- Product
- GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Pack…
- Reason
- Bagel chips containing wheat gluten included in a meal labeled "gluten free."
- Published
- December 14, 2016
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
by Nationwide Laboratories, LLC
- Reason
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
by Ascend Laboratories LLC
- Reason
- Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
- Published
- December 7, 2016
- Distribution
- AL, FL, GA, SC & TN
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
by Burel Pharmaceuticals Inc
- Reason
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Published
- December 7, 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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