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Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination

Friday, August 30, 2013

AUDIENCE: Health Professional, Risk Manager

ISSUE: Wellness Pharmacy, Inc. issues nationwide voluntary recall of certain sterile products due to laboratory results indicating microbial contamination. If there is microbial contamination in medications intended to be sterile,patients are at risk of serious infections which may be life threatening.  To date Wellness Pharmacy has not received any reports of adverse events related to this recall.

BACKGROUND: This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g.,strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on following products: Dexpanthenol 250 mg/mL, Magnesium Sulfate 50%, Methylcobalamin 1 mg/mL, Sodium Phenylbutyrate 200 mg/mL,R.L. Glutathione 100 mg/mL, and Ascorbic Acid (cassava) 500 mg/mL (see firm press release for lot numbers). Recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are ineither clear or amber sterile vials ranging in size from 1ml to 50ml. The medications can be identified by the label on each vial, which will have the name of the drug, strength or concentration, lot number, use by date, and vial size.

RECOMMENDATION: To return medication or request assistance related to this recall, patients and physicians should contact Wellness Pharmacy at 205-879-6551 or 800-227-2627, Monday through Friday, between 9 a.m. and 4 p.m. CDT. Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking these medications.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Firm Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366505.htm

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