Class III · Low risk
Azelastine HCl Nasal Solution
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
FDA Drug Recalls
8 recalls · Class III, newest first
Class III · Low risk
Percocet 10/325 mg tablets
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
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 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 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 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,"