Class II · Moderate risk Terminated
Ubrelvy 100mg 10ud Cplt
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Vaniqa
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution 0.09% 1.7ml Ndc/Upc 62332-508-17
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Metoprolol Tartrate and Hydrochlorothiazide Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Cosopt
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Atropine Sulfate Ophthalmic Solution
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Lidocaine HCL Visc 2% 100ml
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ofloxacin 0.3% 5ml Opth
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Fenofibrate Capsules
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Methocarbamol 500mg 500
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Synthroid
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Creon
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Niacin 250mg 110
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Therapeutic M 130
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Ganirelix Acetate Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
ZOMA-Jet 10 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
ZOMA-Jet 5 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
Omeprazole Delayed-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk Ongoing
aulief
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk Ongoing
China-Gel White
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk Ongoing
China_gel
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk Terminated
Durisan Antimicrobial Solutions
Reason CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.