FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Greencore USA, Inc.
- Product
- Double Smoked Bacon, Cheddar and Egg on Croissant Bun, 5.2 o…
- Reason
- Product may contain metal foreign material in the Croissant Bun.
- Published
- December 14, 2016
- Distribution
- FL, GA, LA, MD, NC, OH, and TX.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Greencore USA, Inc.
- Product
- Slow Roasted Ham and Swiss Croissant, 5.6 oz.
- Reason
- Product may contain metal foreign material in the Croissant Bun.
- Published
- December 14, 2016
- Distribution
- FL, GA, LA, MD, NC, OH, and TX.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Chocolate Shoppe Ice Cream Co., Inc.
- Product
- Yippee Skippee Ice Cream, 3 gallons; UPC 40994-42879
- Reason
- The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes. EXPANDED 11/10/2016 Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.
- Published
- December 14, 2016
- Distribution
- AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Chocolate Shoppe Ice Cream Co., Inc.
- Product
- Sticks & Stones Ice Cream, 3 gallons; UPC 40994-42593
- Reason
- The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes. EXPANDED 11/10/2016 Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.
- Published
- December 14, 2016
- Distribution
- AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Chocolate Shoppe Ice Cream Co., Inc.
- Product
- Peanut Butter Cookie Dough Ice Cream, 3 gallons; UPC 40994-4…
- Reason
- The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes. EXPANDED 11/10/2016 Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.
- Published
- December 14, 2016
- Distribution
- AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Chocolate Shoppe Ice Cream Co., Inc.
- Product
- Heaps of Love Ice Cream, 3 gallons; UPC 40994-43251
- Reason
- The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes. EXPANDED 11/10/2016 Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.
- Published
- December 14, 2016
- Distribution
- AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Chocolate Shoppe Ice Cream Co., Inc.
- Product
- Cookie Dough Ice Cream packed under the following brand name…
- Reason
- The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes. EXPANDED 11/10/2016 Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.
- Published
- December 14, 2016
- Distribution
- AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS,…
View recall →
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
View recall →
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 →
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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