Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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
Native Fluoride Toothpaste for Sensitive Teeth
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
Advance Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
ProtectoRx
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
DiBAR LABS Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
Imperia Elita Vitaccino Coffee
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk
Sterile Water for Inj.
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class II · Moderate risk
Cefixime for Oral Suspension USP 100 mg/5mL
Subpotent Drug
Class II · Moderate risk
Sodium Chloride 0.9%
Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk
Preferred Pharmaceuticals Inc.
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Methylprednisolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Transdermal System Delivers 0.0375 mg/day
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk
Oxygen
cGMP deviations