Class II · Moderate risk
7 Eleven FOR GAS ISLAND USE ONLY
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
PROBLEND E3 Foaming Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class I · High risk
ForeverMen Natural Energy Boost Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Class II · Moderate risk
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide)
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II · Moderate risk
Telmisartan Tablets
Failed Stability Specifications: Out of specification for blend uniformity.
Class III · Low risk
Mercaptopurine Tablets
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Class II · Moderate risk
HydrALAZINE Hydrochloride Tablets
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class II · Moderate risk
Bicillin L-A
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Infuvite Adult Multiple vitamins injection
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Rocuronium Bromide Injection
cGMP Deviations: Products were stored outside the drug label specifications.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk
Voriconazole for Oral Suspension
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
HydrALAZINE Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk
Pure Care Foaming Mint Hand Sanitizer 62%
CGMP Deviations
Class II · Moderate risk
Febuxostat Tablets
CGMP Deviations
Class II · Moderate risk
Equate Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Kroger Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Meijer Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
CVS Health Cherry Cough Drops
CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk
Omeza Skin Protectant
CGMP Deviations
Class II · Moderate risk
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
CGMP Deviations