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
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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
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FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
by Akorn Inc
- Reason
- Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: OOS results for known compound.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
by Pfizer Inc.
- Reason
- Superpotent
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Stability Specifications: Low Out of Specification results for alcohol content.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
by West-Ward Pharmaceuticals Corp.
- Reason
- Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
by VistaPharm, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EN-R-G Foods, Inc.
- Product
- Protein Chews Juneberry,1.8oz, film package, 12 packets per…
- Reason
- EN-R-G Foods is recalling Cherry Lime Protein Chews, Raspberry Protein Chews, Juneberry Protein Chews due to complaints of nausea and/ or vomiting after consumption.
- 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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