Class I · High risk
Artri King Reforzado con Origa y Omega 3 tablets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
FDA Drug Recalls
316 recalls, newest first
Class II · Moderate risk
Equate Hand Sanitizer
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
DOP Instant Hand Sanitizer
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
DOP Instant Hand Sanitizer
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
Deferasirox Tablets for Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Oxaydo (oxycodone HCl, USP)
Sub-potent Drug: Lower potency than labeled.
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
Class III · Low risk
Synthroid
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
The Rock
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
Certain Over-The-Counter
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk
Gynazole-1
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
Triamcinolone Acetonide Injectable Suspension
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.
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk
TheraBreath for Kids! Oral Rinse
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class II · Moderate risk
octiq Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
MAJOR LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility