Class II · Moderate risk
Blemfree All Day Lotion
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
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.
14,535 recalls, newest first.
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk
Venlafaxine Hydrochloride
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Class II · Moderate risk
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class II · Moderate risk
Phenazopyridine HCl
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications