Class II · Moderate risk
HEPERAIN 50 mg/50 mL
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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
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
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class II · Moderate risk
Losartan Potassium Tablets
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
Lipoic Acid Injection
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class II · Moderate risk
Cephalexin for Oral Suspension USP 250mg/5 mL
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
Cephalexin for Oral Suspension USP
CGMP Deviation; manufacturing batch record could not be located
Class II · Moderate risk
Lidocaine gel 1%
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.05%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.2%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 0.5%
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 1%
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B12 liquid 1000mcg/ml
Lack of sterility assurance.
Class II · Moderate risk
Testosteron Cypionate liquid 200mg/ml
Lack of sterility assurance.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Class II · Moderate risk
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine/Epinepherine liquid 1%/ 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine gel 2%
Lack of sterility assurance.
Class II · Moderate risk
Hydroxyprogesterone liquid
Lack of sterility assurance.
Class II · Moderate risk
HCG liquid
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Epinephrine liquid 1:1000
Lack of sterility assurance.
Class II · Moderate risk
Cyclosporin liquid 2%
Lack of sterility assurance.
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.