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
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 →
FDA Recall
Terminated
Historical recordClass II
Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
by Par Pharmaceutical, Inc.
- Reason
- Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
purely elizabeth.
- Product
- Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz,…
- Reason
- Chocolate Sea Salt Probiotic Granola due to undeclared soy lecithin.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, FISH SOUP, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, GUNGO PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Island Soups Company Inc.
- Product
- ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)
- Reason
- Possible contamination with Clostridium botulinum
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Rosa Foods HQ
- Product
- Soylent Food Bars, Net Wt. 2.12 oz (60g), 12 pack.
- Reason
- Rosa Foods is recalling Soylent Bar because a number of their customers have experienced gastrointestinal issues after consuming Soylent Bars.
- Published
- December 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
- Published
- November 30, 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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