Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk Ongoing
Kuka Flex Forte caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Reumo Flex caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Artri King Reforzado con Origa y Omega 3 tablets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class II · Moderate risk Ongoing
Equate Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
Deferasirox Tablets for Oral Suspension
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Oxaydo
Reason Sub-potent Drug: Lower potency than labeled.
Class I · High risk Ongoing
Elcys
Reason Presence of Particulate Matter: Silicone
Class I · High risk Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Reason Presence of Particulate Matter: Silicone
Class I · High risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: Silicone
Class III · Low risk Ongoing
Synthroid
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class I · High risk Ongoing
The Rock
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk Ongoing
Certain Over-The-Counter
Reason CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Gynazole-1
Reason Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk Ongoing
Triamcinolone Acetonide Injectable Suspension
Reason Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.