Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets
Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Abelcet
Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class II · Moderate risk Terminated
Posaconazole Delayed-Release Tablets
Reason Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Class II · Moderate risk Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class II · Moderate risk Ongoing
Artificial Tears
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
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
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 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 Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.