Menow Sunscreen Pressed Powder SPF35 PA+++
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ has cGMP deviations.
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ has cGMP deviations.
Puralube Vet Ointment has cGMP deviations.
Vancomycin Injection, USP in 5% Dextrose has CGMP deviations.
17 productsZicam Cold Remedy Medicated Nasal Swabs have out of limit results for microbiological testing.
Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.
Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.
5 productsMirabegron Extended-Release Tablets contain an impurity above specification.
Azelaic Acid Gel, 15%, 50 gram tubes may have abnormal texture or consistency described as grainy, gritty, or sandy.
Pemetrexed, Bortezomib, and Azacitidine for Injection lack sterility assurance.
4 productsClomiphene Citrate USP Active Pharmaceutical Ingredient has cGMP deviations.
CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
3 productsCGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
3 productsAn incorrect detergent was used and required swab sampling was not performed on a production hopper.
Duloxetine D/R contains an impurity above the FDA recommended interim limit.
Corlanor (ivabradine) tablets contain a foreign substance, and Sensipar (cinacalcet) Tablets have CGMP deviations.
5 productsFenofibrate Capsules, USP 200 mg, have CGMP deviations.
Reason given by FDA: CGMP Deviations; deficiencies observed during FDA inspection.
14 productsDuloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.
2 productsDuloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.
Reason given by FDA: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
2 productsDuloxetine Delayed-Release Capsules contain an impurity above the recommended limit.
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.
3 productsIVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.
2 productsInjectable solutions of phenylephrine, fentanyl, and ketamine have cGMP deviations.
7 productsCGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Clonidine Transdermal System was made with an unapproved raw material.
3 productsReason given by FDA: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit.
3 productsBlaine Labs Wound Care Gels and Antifungal Creams and Solutions have manufacturing deviations or bacterial contamination.
8 productsPrazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.
3 productsBZK Antiseptic Towelettes have CGMP deviations.
21 productsReason given by FDA: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution.
2 productsBisoprolol Fumarate and Hydrochlorothiazide tablets fail to meet impurity specification limits.
The Aquarion Preserved Cartridges have cGMP deviations.