Class II · Moderate risk Terminated
Estradiol Hemihydrate USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Estradiol USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Duloxetine HCl USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Doxycycline Hyclate USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Diphenhydramine HCl USP f
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Diclofenac Sodium USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Desoximetasone USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Cyclosporine USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Cyclobenzaprine HCl USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Clonidine HCl USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Clindamycin Phosphate USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Celecoxib USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Calcipotriene BP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Baclofen USP
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Anastrozole USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
Amitriptyline HCl USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk Terminated
100 mcg / mL Phenylephrine HCl
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk Terminated
0.2% Ropivacaine HCI
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk Terminated
15 units Oxytocin added to 0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk Terminated
Velcade
Reason Defective Container: Confirmed reports of loose vial crimps.
Class II · Moderate risk Terminated
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24…
Reason CGMP deviations.
Class II · Moderate risk Terminated
Mycamine
Reason Labeling: Label Error on Declared Strength
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II · Moderate risk Terminated
TAD Glutathione Whitening Kits lyophilized powder for injection
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk Terminated
Saluta Glutathione Whitening kits
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.