Class II · Moderate risk
S.P.Labs
Failed Stability Specifications
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
FentaNYL citrate
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility: Firm did not perform process validation.
Class II · Moderate risk
hyalogic For Dry Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Red Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Pink Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Aging Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Floaters Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye strain Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Dryness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Eye Twitching Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Blur Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Allergy Eyes Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Methylprednisolone acetate Injectable Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin 5mg/ml
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin PF
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
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.