Class II · Moderate risk
Tri-Lo-Sprintec
Failed Dissolution Specifications
FDA Drug Recalls
166 recalls, newest first
Class II · Moderate risk
Potassium Chloride for Injection Concentrate USP
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class II · Moderate risk
Betimol (timolol ophthalmic solution)
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Class II · Moderate risk
PROBLEND Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven Hand Sanitizer Gel
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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.
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