Class II · Moderate risk
Aleve Analgesic Back Muscle 24 Ct Sku 999787 Aleve Pm Caplets…
CGMP Deviations: product held outside appropriate storage temperature conditions.
FDA Drug Recalls
18,003 recalls, newest first
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 III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
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 III · Low risk
Mometasone Furoate
Defective Container
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 I · High risk
CVS Health Magnesium Citrate SALINE LAXATIVE
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens