Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
DermOtic Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Class III · Low risk
Carisoprodol Tablets
Failed Impurity/degradation Specification
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Zithromax (azithromycin for injection)
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Class III · Low risk
Qnasl (beclomethasone dipropionate)
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablet
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.