Class II · Moderate risk
DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed…
CGMP Deviations: product held outside appropriate storage temperature conditions.
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
Aleve Analgesic Back Muscle 24 Ct Sku 999787 Aleve Pm Caplets…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dr Scholls Anti Fungal Spray Pwder 4.7 Oz Sku 998250 Premier…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Motrin Ib Caplets 24ct Sku999394
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Softsoap Anti Bactrial Lq Soap 11.25 Floz Sku 2005090 Dial Lhs…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Suave Inv Sld Pwdr 1.2 Oz Sku2004504 Suave Ap Inv Solid Sweet…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Colgate Max Fresh Clean Mint 1.9oz Sku 900596 Colgate Cavity…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Banana Boat Sprt Clr Spry Spf50 6 Fl Oz Sku 2007524 Suntone…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II · Moderate risk
70% ISOPROPYL ALCOHOL First aid antiseptic
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg per suppository
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg capsules
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection