Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
FDA Drug Recalls
775 recalls, newest first
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Tirosint - Sol
Subpotent Drug
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class III · Low risk
Clobetasol propionate Cream USP
Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk
Ohm Sanitizer Spray
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Ohm Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Allopurinol Tablets 100mg
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk
S2 Racepinephrine Inhalation Solution
Short Fill
Class II · Moderate risk
Class III · Low risk
FentaNYL Citrate 2.5mg/50mL
Short Fill: Underfilled units.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
Allopurinol Tablets USP
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.