Compounded Sterile Drug Product Recalls Regarding Sterility and Quality Control – UPDATED
April 2, 2015
FDA has alerted healthcare professionals and the public about multiple sterile compounding pharmacies having quality control and sterility issues. This alert does not include the New England Compounding Center information that was associated with fungal infections associated with their products. Multistate recalls have been implemented in various degrees of sterile products from these pharmacies. To date, FDA has not received reports of injury or illness due to these products unless specified. The companies and details of the recalls include the following:
Abrams Royal Pharmacy – Recall of all unexpired sterile drug products due to lack of sterility concerns. Ameridose, LLC – Recall of all unexpired drug products. ApothéCure, Inc. – All sterile compounded drug products recalled that are not expired. Balanced Solutions Compounding Pharmacy, LLC – All sterile compounded drug products recalled that are not expired, including injectable and ophthalmic agents. Avella Specialty Pharmacy – Recall of 2 compounded sterile medications due to the possibility of inaccurate sterility testing by Front Range Labs. For information on lot numbers and a complete list of recalled items see the Firm Press Release for Avella Specialty Pharmacy at the link below. Beacon Hill Medical Pharmacy/Rxtra Solutions – Recall of all lots of certain sterile compounded drug products. For information on lot numbers and a complete list of the over 100 recalled items see the Firm Press Release for Beacon Hill Pharmacy at the link below. Clinical Specialties Compounding Pharmacy – Recall of all sterile compounded drug products. The Compounding Shop, LLC of St. Petersburg, Florida – All sterile compounded drug products recalled. These products were distributed locally. There is also an additional FDA warning to quarantine budesonide solution products used for nasal irrigation. FDA identified fungus in one of the bottles. Downing Labs LLC (also known as NuVision Pharmacy) – All sterile compounded drug products. Green Valley Drugs of Henderson, Nevada – Recall of all sterile compounded drug products. JCB Laboratories – Recall of 6 lots of sterile compounded products due to the possibility of inaccurate sterility testing by Front Range Labs. For information on the recalled products and lot numbers, see the Firm Press Release for JCB Laboratories at the link below. Leiter’s Compounding Pharmacy – Recall of certain lots of sterile compounded bevacizumab and lidocaine / phenylephrine products due to the possibility of inaccurate sterility testing by Front Range Labs. For information on the recalled products and lot numbers, see the Firm Press Release for Leiter’s Compounding Pharmacy at the link below. Main Street Family Pharmacy of Newbern, Tennessee – All sterile compounded drug products have been recalled due to possible microbial contamination. Bacterial and fungal growth were found in 2 unopened, 10 mL vials of preservative-free methylprednisolone acetate 80 mg/mL injection (lot numbers: from lots #011413dan and #010913dan). CDC and FDA are working together to identify the species of these microbes. FDA has received 7 adverse reaction reports of skin abscesses associated with methylprednisolone acetate injection; an investigation is still ongoing. FDA has not received any reports of meningitis attributed to preservative-free methylprednisolone acetate compounded by Main Street Family Pharmacy. Med Prep Consulting, Inc. of Tinton Falls, New Jersey – Regional recall of all compounded drug products. Mold was found in magnesium sulfate 2 gram/50 mL bags for injection upon inspection. Medaus Pharmacy – Recall of specific sterile compounded products. Unable to confirm sterility of certain lots. For information on lot numbers and a complete list of recalled items see the Firm Press Release for Medaus Pharmacy at the link below. Nora Apothecary & Alternative Therapies – Recall of all sterile compounded drug products that are not expired. NuVision Pharmacy of Dallas, Texas – All sterile compounded drug products recalled. FDA has received adverse reaction reports of injection-site reactions, along with fever and flu-like symptoms with methylcobalamin injection. Olympia Pharmacy – Recall of all sterile compounded drug products with a use by date of 09/25/13 or earlier. Pallimed Solutions, Inc. of Woburn, Massachusetts – All sterile compounded drug products recalled that were dispensed since January 1, 2013. Visible particles were seen in 5 inspected vials of sterile compounded products. Park Compounding – Recall of 1 lot of testosterone cypionate (sesame oil) 200 mg/mL (lot #05072013@1 exp: 11/3/13). Sterility testing methods used may have given inaccurate results. Affected products were distributed to California and Indiana directly to doctors’ offices and patients. Products were sold in May and June 2013. Park Pharmacy & Compounding Center of Irvine, California – Recall of 1 lot of methylcobalamin 5 mg/mL injection (lot # 06132013@1) and 1 lot of Multitrace-5 concentrate 10 mL injection (lot #05212013@20) due to possible microbial contamination. Sterility testing methods used may have given inaccurate results. Affected products were distributed to California, Florida, New Mexico, and Indiana. Pentec Health, Inc. – All lots of sterile nutritional prescriptions for renal patients recalled that are not expired. A total of 163 patient prescriptions are included in this recall. Discontinue and quarantine any unexpired nutritional prescriptions compounded on or before May 2, 2013. Prescription Center pharmacy of Fayetteville, North Carolina – All sterile and non-sterile compounded or repackaged products that were distributed between September 10, 2014, and March 10, 2015 are recalled. The North Carolina Board of Pharmacy ordered Prescription Center pharmacy to close due to concerns about the sterility, stability, and potency of their products. Affected products were distributed nationwide and to Canada, and included both human and veterinary products. Specialty Compounding, LLC, (a subsidiary of Peoples Pharmacy Inc.) of Cedar Park, Texas – Bacterial infections consistent with Rhodococcus species were found in samples of calcium gluconate 2 gram presentations. Fifteen reports to FDA from 2 hospitals in Texas found bacterial infections in the blood caused by Rhodococcus equi in patients who received calcium gluconate compounded by Specialty Compounding, LLC. There is potential association between the infected patients and the compounded products. All sterile compounded drug products are recalled that were dispensed since May 9, 2013. Products were distributed nationally except to North Carolina. University Compounding Pharmacy of San Diego, California – Recall of certain sterile compounded products due to the possibility of inaccurate sterility testing. For information on the recalled products and lot numbers, see the Firm Press Release for University Compounding Pharmacy at the link below. Wellness Pharmacy, Inc. – Recall of certain lots of sterile compounded products due to the possibility of inaccurate sterility testing by Front Range Labs. For information on the recalled products and lot numbers, see the Firm Press Release for Wellness Pharmacy at the link below.
Discontinue and quarantine all sterile products from these recalls. Detailed instructions are available in the links below. FDA encourages consumers and healthcare professionals to report adverse reactions to FDA’s MedWatch Program at www.fda.gov/medwatch.
