Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class III · Low risk Terminated
Clobetasol propionate Cream USP
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk Terminated
Ohm Sanitizer Spray
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Ohm Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Allopurinol Tablets 100mg
Reason 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 Terminated
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk Terminated
S2 Racepinephrine Inhalation Solution
Reason Short Fill
Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Short Fill
Class III · Low risk Terminated
FentaNYL Citrate 2.5mg/50mL
Reason Short Fill: Underfilled units.
Class II · Moderate risk Terminated
Sterile Water for Injection
Reason CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk Terminated
Allopurinol Tablets USP
Reason 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 Terminated
Metoprolol Succinate Extended-Release Tablets
Reason 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 Terminated
Rocuronium Bromide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specification