Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Gordofilm Wart Remover
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Class II · Moderate risk
fentaNYL Citrate 2
Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of assurance of sterility: bags have the potential to leak..
Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class II · Moderate risk
Tri-Lo-Sprintec
Failed Dissolution Specifications
Class II · Moderate risk
Potassium Chloride for Injection Concentrate USP
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class II · Moderate risk
Betimol (timolol ophthalmic solution)
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
S.P Labs
Failed Stability Specifications