Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
FDA Drug Recalls
34 recalls, newest first
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class II · Moderate risk
Metronidazole Tablets
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Class II · Moderate risk
Methylprednisolone Tablets
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Class II · Moderate risk
Concentrated Sodium Chloride Injection
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Class III · Low risk
Earth Force
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
Class III · Low risk
Plavix 75 mg
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Class III · Low risk
Metoclopramide Oral Solution
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"