Class II · Moderate risk
DermaSarra
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
DermaMed Ointment
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
DermaKleen
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
DermaFungal
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
DermaCerin
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
4-N-1 Skin Protectant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation USP. Isotonic Solution for Irrigation
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class III · Low risk
TopCare Health 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class III · Low risk
Kroger 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
Class II · Moderate risk
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50…
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk
Ultra Violette
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Class II · Moderate risk
Carvedilol Tablets USP
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Class III · Low risk
Readyprep Pvp
Subpotent drug
Class II · Moderate risk
Dextroamphetamine Saccharate
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter.
Class I · High risk
Lactated Ringers's Injection USP
Presence of Particulate Matter
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.