HYDROXYZINE HYDROCHLORIDE 10 mg/5mL

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

Qualitest Pharmaceuticals

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Hi-Tech Pharmacal Co., Inc.

Subpotent; 24 month stability test station

Advanced Physician Solutions, Inc.

Lack of Assurance of Sterility

Hi-Tech Pharmacal Co., Inc.

Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.

Morton Grove Pharmaceuticals, Inc.

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

Lannett Company, Inc.

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

Akorn, Inc.

Failed Impurities/Degradation Specifications