Class II · Moderate risk
Healthful Naturals Leg Cramp Support Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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.
14,543 recalls, newest first.
Class II · Moderate risk
Healthful Naturals DizziFree Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Magnesium Sulfate in Water for Injection
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class II · Moderate risk
Tesamorelin
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Class II · Moderate risk
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
Prevacid 24HR
CGMP deviations
Class II · Moderate risk
Lidocaine 1% + Epinephrine 1:100
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets USP
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Class II · Moderate risk
Glipizide XL
CGMP Deviations; rejected product was used to manufacture final bulk lot
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk
Elelyso (taliglucerase alfa)
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class II · Moderate risk
SparkleFresh Fluoride Toothpaste
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class II · Moderate risk
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone in Grapeseed Oil 200 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Sulfate 1 mg/mL MDV Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Water Sterile for Injection 250 mL IV Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Vigamox Oph. Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility