Walgreen’s Company recalls 33 products after two FDA inspections find issues

FDA finds issues with Walgreens’ infusion compounding services

http://www.fiercepharmamanufacturing.com/story/fda-finds-issues-walgreens-infusion-compounding-services/2016-01-13

Company recalls 33 products after two inspections find issues

The FDA has been making its way through inspections of the country’s largest compounders and has found issues with Option One, which was formed last year when Walgreens ($WBA) sold its infusion care services to a private equity group. The service is recalling nearly three dozen products after two inspections of its Option One compounding operations in Texas were found to be short on sterility precautions.

The recall includes 33 products ranging from saline and dextrose, to heparin, insulin, vancomycin, milrinone and compounded Remicade. It comes after inspections last year and in 2014 that found a host of problems at the Dallas facility that call into question the sterility of the products made at compounding center. The first inspection came before Walgreens sold control of the business to Madison Dearborn Partners of Chicago for an undisclosed sum, keeping a “significant minority interest” for itself.

According to the Form 483s, there were some problems with airflow in the ISO rooms and a lack of stability testing for products including Dextrose 5% and 0.9% Sodium Chloride 3000 mL, as well as the hospital antibiotic Cubicin, that Option One had manufactured. An inspector saw aseptic manufacturing problems like masks that did not fully cover workers’ faces and one worker who reused a sterile glove that had been dropped on the floor. In a warehouse that sits adjacent to the manufacturing area, an inspector saw “what appeared to be hundreds of dead insects throughout.”

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Sign up for our FREE newsletter for more news like this sent to your inbox!The FDA assumed more oversight of the compounding industry in 2014 with the passage of the Drug Quality and Security Act. The new requirements were put in place after a fatal outbreak of fungal meningitis was tracked back to unsterile conditions at the compounding facility where it was produced. Since the agency started inspecting compounding pharmacies, dozens have been required to recall all of their sterile products in response to issues the FDA uncovered.

One of those was Dallas-based Downing Labs, which found itself in deeper problems last week. The FDA reported that a federal court had issued a consent decree against the compounder, its owners and lead pharmacist. It claimed the compounder had continued to manufacture adulterated drugs even after repeated warnings about sterility issues.

Some companies see opportunities in the shortcomings of the compounding industry. AmerisourceBergen ($ABC) laid out $2.575 billion last fall to get its hands on PharMEDium Healthcare Holdings, a large national compounding operation, while QuVa was formed in August with a capital infusion from Bain Capital. QuVa’s Temple, TX, compounding facility was one of the first to receive an Establishment Inspection Report, which it said recognized its “effort to not only meet, but to exceed FDA standards.”

– the recall notices can be found here
– read the 2015 Form 483
– here’s the 2014 Form 483

Related Articles:
Texas compounder that has been fighting FDA recalls all its drugs
​AmerisourceBergen lays out $2.5B for sterile compounder PharMEDium
Texas compounder corralled by federal injunction
New Jersey compounder indicted over unsanitary manufacturing

Compounders start to sign up for FDA oversight

3 Responses

  1. I’ve been calling you as to what to do about the recall on Hydrochlorothiazide & can’t get any answers ,what am.I supposed to do it I can’t get answers from you in the phone ? I’ve spent 45 minutes waiting for an answer .I have to pay for my minutes .Please help

    • I have no record of getting a phone call and I don’t put people on hold… the post that you posted this comment against is almost THREE YEARS old… I am not aware of any recall on HCTZ

      • Hydrochlorothiazide Tablets Recalled at Consumer Level. Accord Healthcare Inc. is voluntarily recalling 1 lot of Hydrochlorothiazide Tablets USP, 12.5 mg, at the consumer level, due to a potential labeling mix-up. … To date, Accord has not received any reports of adverse events related to the recall of Lot PW05264.Aug 28, 2018

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