Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
Class II · Moderate risk
Tizanidine HCl Tablets
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk
Arthritis Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Colds & Flu Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Allergy & Hay Fever Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Muscle & Joint Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Diarrhea Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sore Throat & Laryngitis Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sinus Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Skin Irritation & Itch Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Class II · Moderate risk
Thyroid powder
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Ethosuximide Capsules
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Class II · Moderate risk
Thyroid Powder
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk
Cortaid 12-Hour Advanced Anti-itch Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Maximum Strength Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Intensive Therapy Cooling Spray
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Children s Advil Suspension Ibuprofen Oral Suspension
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Class II · Moderate risk
Cefuroxime 10mg/mL INJ 0.5 mg
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper