Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
Lack of sterility assurance.
Prescription and over-the-counter medications
CMC Enterprise Pharmacy
Lack of sterility assurance.
CMC Enterprise Pharmacy
Lack of sterility assurance.
CMC Enterprise Pharmacy
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Brian P. Richardson
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Dr. Reddy's Laboratories
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc.
Lack of sterility assurance.
Iso-Tex Diagnostics
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.