Mailed Compounded Prescriptions Recalled Due to Non-Sterility

Pharmacy Creations of Randolph, New Jersey, recalled four products following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential for not being sterile. If the products are not sterile there are serious health implications including development of a life-threatening infection.


The prescription preparations listed below were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014, and June 18, 2014, and were mailed directly to patients and physicians.


The recall affects two antioxidants: Ascorbic Acid, 500 mg/mL in a 50 mL vial with lot number 05082014@7, expiring 11/4/2014 and Glutathione, 100 mg/mL in a 30 mL vial with lot number 05122014@4, expiring 9/9/2014. A mineral supplement is also being recalled: Magnesium Chloride, 200 mg/mL in a 50 mL vial with lot number 05202014@7, expiring 11/19/2014. The final recalled product is a multidrug combination: Tropi/Cyclo/Phenyl/Tobra/ Flurb (1/1/10/0.3/0.3)% in 3 mL vial with lot number 05202014@3 expiring 11/16/2014.


See the Recall


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication