Class II · Moderate risk
CVS Pharmacy Fiber Capsules for Regularity
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Best Choice Health Care
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Preservative-Free MORPHINE Sulfate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class II · Moderate risk
Atrovent HFA Inhalation Aerosol
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Class II · Moderate risk
I-C Drops
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Class II · Moderate risk
Doxazosin Tablets
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Citalopram tablets USP
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
Class II · Moderate risk
Levetiracetam Tablets
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Class II · Moderate risk
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Class II · Moderate risk
Ventolin HFA
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
Class II · Moderate risk
Thyro-Tab 0.075 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
Class II · Moderate risk
Thyro-Tab 0.050 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
OFIRMEV (acetaminophen)
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
CMS-2374-R4 Custom US Breast Core Biopsy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
CMS-8934 Custom Phlebectomy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.