Class III · Low risk
E-Z-HD (barium sulfate)
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
FDA Drug Recalls
129 recalls · Class III, newest first
Class III · Low risk
Lortuss Ex
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class III · Low risk
Poly-Tussin Ac Liquid
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class III · Low risk
Tolterodine Tartrate Tablets
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Class III · Low risk
Diltiazem HCl Extended Release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk
Cardura XL
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Class III · Low risk
Aspirin DR Enteric Coated Tablets
Failed Dissolution Specification; at the 12 month time interval.
Class III · Low risk
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Apri (desogestrel and ethinyl estradiol tablets USP)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
DENBLAN Anticavity Fluoride Toothpaste
Stability Data Does Not Support Expiry
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Class III · Low risk
Vasotec (enalapril maleate)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Class III · Low risk
Vaseretic (enalapril maleate/hydrochlorothiazide)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Class III · Low risk
Oasis TEARS
Labeling: Missing Label; The label on the immediate bottle is missing.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class III · Low risk
Triveen - PRx RNF Capsules
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Class III · Low risk
Wockhardt Metoprolol Succinate
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.