Acetylcysteine 100 mg/mL

Promise Pharmacy, LLC

Lack of sterility assurance.

The Apothecary Shoppe LLC

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Pharmacy Innovations

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Bedford Pharmacy

Lack of assurance of sterility

Pharmacy Plus, Inc. dba Vital Care Compounder

Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Specialty Medicine Compounding Pharmacy

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Wise Pharmacy

Lack of Processing Controls

Pallimed Solutions

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Ben Venue Laboratories Inc

Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution