Class II · Moderate risk Terminated
Dymista
Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II · Moderate risk Terminated
Ephedrine Sulfate
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
LET Gel 4%
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk Terminated
BromSite
Reason Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk Terminated
Fexofenadine HCl Tablets
Reason Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class II · Moderate risk Terminated
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
Docusate Sodium
Reason Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
infants* IBUPROFEN
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Class II · Moderate risk Terminated
HEPERAIN 50 mg/50 mL
Reason Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Class II · Moderate risk Terminated
Fluocinolone Acetonide Topical Solution
Reason Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Reason Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Class II · Moderate risk Terminated
Lipoic Acid Injection
Reason Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension USP 250mg/5 mL
Reason CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension USP
Reason CGMP Deviation; manufacturing batch record could not be located
Class II · Moderate risk Terminated
Lidocaine gel 1%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione liquid
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.05%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.2%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Cyclosporin liquid 0.5%
Reason Lack of sterility assurance.