Sterility Concerns at 3 More Pharmacies Prompt Recalls

Megan Brooks

Disclosures

August 27, 2013

Three more compounding pharmacies are recalling products because of concerns that some of their products may not be sterile, the US Food and Drug Administration (FDA) has announced.

Front Range Laboratories, in Loveland, Colorado, are at the center of 2 of the recalls.

On August 26, JCB Laboratories recalled 6 lots of sterile drug products to the user level because of concerns about sterility assurance after a recent FDA inspection of Front Range Labs, one of the contract testing labs used by JCB.

The recalled products were distributed to outpatient dialysis clinics in multiple states from July 8 through August 20, 2013.

After an inspection of Front Range Labs, the FDA issued an alert to pharmacies on August 21 stating that "the methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

Table 1. Front Range Labs products, lot numbers, and expiration dates

Product Lot number Expiration date
Sodium thiosulfate 25%, 250 mg/mL 130701@9 December 28, 2013
  130709@6 January 5, 2014
  130717@2 January 13, 2014
Sodium citrate 4% solution injection, 30-mL multiple-dose vial 130710@4 January 6, 2014
Sodium citrate 4% w/gentamicin, 320-μg/mL multiple-dose vial 130620@2 December 17, 2013
Acetylcysteine, 20% solution for inhalation, 4-mL single-dose vials 130627@5 August 26, 2013

"Out of an abundance of caution, JCB has discontinued its relationship with Front Range and is now testing products at a different laboratory," the company said.

JCB has not received any reports of adverse events related to this recall to date, the company noted. However, if there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

JCB is notifying its customers by telephone, email, fax, and mail. To return product or request assistance related to this recall, users should contact JCB Laboratories at 316-773-0405, Monday through Friday, between 8 am and 5 pm CDT.

Similar Concerns at Second Pharmacy

Concerns at Front Range Labs have also prompted Wellness Pharmacy Inc, in Birmingham, Alabama, to recall 6 products.

Table 2. Wellness Pharmacy Inc products, lot numbers, and expiration dates

Product Lot number Expiration date
Dexpanthenol, 250 mg/mL 130605@52 December 2, 2013
Magnesium sulfate 50% 130613@38 December 10, 2013
Methylcobalamin, 1 mg/mL 130612@49 December 9, 2013, and October 19, 2013
Sodium phenylbutyrate, 200 mg/mL SDV PF 130621@28 October 19, 2013
RL glutathione, 100 mg/mL SUV PF 130710@27 January 6, 2014
Ascorbic acid (cassava), 500 mg/mL PF SUV 130711@13 January 7, 2014

The recalled medications were distributed to individual patients and to physician offices nationwide. These liquid medications are in either clear or amber sterile vials ranging in size from 1 to 50 mL, the company said. 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.

Wellness Pharmacy is notifying its customers by telephone and regular mail of this recall. "Patients and physicians should immediately discontinue use of these lots of medications, and return the recalled unexpired medications to Wellness Pharmacy," the company advises.

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 am and 4 pm CDT.

Testing Issues at Third Pharmacy

On August 23, Park Pharmacy & Compounding, in Irvine, California, voluntarily recalled to the consumer level 2 lots of methylcobalamin 5 mg/mL 30-mL amber vials with lot number 06132013@1 and an expiration date of December 10, 2013.

The company also recalled to the consumer level multitrace-5 concentrate 10-mL amber vials for injection with lot number 05212013@20 and an expiration date of November 17, 2013.

This recall was also prompted by a recent FDA inspection of the laboratory used by this pharmacy, although the laboratory was not named in the company release, which was posted on the FDA Web site.

The prescription preparations were sold during June and July 2013 in California, Florida, New Mexico, and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail).

"To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. We are voluntarily recalling the products as a precautionary measure for the safety of our patients," the company said.

Park Pharmacy & Compounding is notifying its customers by telephone and mail and is arranging for return of all recalled product lots. Customers with product being recalled should stop using it and contact Park Pharmacy & Compounding to arrange for return of the unused product. Customers with questions regarding this recall can contact Park Pharmacy & Compounding at 949-551-7195 Monday through Friday, 9 AM to 5 PM PST, or email the company at at info@parkrx.com.

To report problems with these products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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