Class III · Low risk Terminated
Tivicay
Reason Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Photofrin
Reason Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Class III · Low risk Terminated
Gelnique
Reason Subpotent Drug: Drug potency was compromised during shipment.
Class III · Low risk Terminated
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid
Reason Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Class III · Low risk Terminated
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
DermOtic Oil
Reason Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk Terminated
Triamcinolone Acetonide Cream USP
Reason 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 Terminated
Carisoprodol Tablets
Reason Failed Impurity/degradation Specification
Class III · Low risk Terminated
Suprax
Reason Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk Terminated
Suprax
Reason Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk Terminated
Liptruzet
Reason 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 Terminated
Liptruzet
Reason 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 Terminated
Liptruzet
Reason 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 Terminated
Liptruzet
Reason 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 Terminated
Zithromax
Reason Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
Class III · Low risk Terminated
Cetirizine Hydrochloride Syrup
Reason Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk Terminated
VoLumen Barium Sulfate Suspension
Reason Failed Stability Testing: This product is below specification for preservative content.
Class III · Low risk Terminated
Folic Acid Injection
Reason Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point