Class II · Moderate risk Ongoing
Minocycline Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Gasco Isopropyl Alcohol 70%
Reason Subpotent drug
Class II · Moderate risk Ongoing
Budesonide Inhalation Suspension
Reason Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Class II · Moderate risk Ongoing
GSMS Incorporated
Reason Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class II · Moderate risk Ongoing
BD ChloraPrep FREPP Clear
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk Ongoing
BD ChloraPrep Clear
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II · Moderate risk Ongoing
Fenofibrate Capsules
Reason CGMP Deviations
Class II · Moderate risk Ongoing
TopCare health
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
TopCare health
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
EQUALINE ultra strength
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
EQUALINE extra strength
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
GOODSENSE Ultra Strength
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
GOODSENSE Extra Strength
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
H.E.B Extra Strength Calcium Carbonate Antacid Tablets
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
HyVee
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
HyVee
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
Harris Teeter
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
Family Wellness
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
Family Wellness
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Class II · Moderate risk Ongoing
DISCOUNT drug mart
Reason Presence of foreign substance: small metallic particles in chewable tablets.