Ethanol 70 mL/100mL

Aroma Release Technologies Inc

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Western Drug

Lack of Assurance of Sterility

Natures Pharmacy & Compounding Center

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Baptist Health Medical Towers Pharmacy and Infusion Services

Lack of Sterility Assurance

AnazaoHealth Corporation

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Urban Electric Power

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Grato Holdings, Inc.

Labeling mix-up - Indications on product label are incorrect.

Acuity Specialty Products, Inc.

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.