Class II · Moderate risk
Ofloxacin 0.3% 5ml Opth
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methocarbamol 500mg 500
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synthroid (levothyroxine sodium tablets, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Creon (pancrelipase)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Niacin 250mg 110
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Therapeutic M 130
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
ZOMA-Jet 10 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
ZOMA-Jet 5 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk
aulief (Organic Camphor 3.00% Organic Menthol 5.00%)
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
China-Gel White
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
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
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
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
Durisan Antimicrobial Solutions
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Class II · Moderate risk
0.9% SODIUM CHLORIDE Irrigation
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class II · Moderate risk
Nortriptyline HCL capsules
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Class II · Moderate risk
Progesterone Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel.