Class II · Moderate risk
Elixir by Coco March Tinted Mineral Sunscreen SPF 50
CGMP Deviations
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
Elixir by Coco March Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
Class II · Moderate risk
Gabriel Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Cream
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Balm with Tea Tree Oil
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor. D. Schwab Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
HADLIMA (adalimumab-bwwd)
Lack of Assurance of Sterility.
Class II · Moderate risk
Niacin Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk
Taoscare Motion Sickness Patches 36-count box
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk
Fasenra (benralizumab)
Lack of Assurance of Sterility:
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk
Prazosin Hydrochloride
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.