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FDA Recommends Staying Away From Compounding Pharmacy

This week the FDA released a notice that a compounding pharmacy has voluntarily recalled certain human and veterinary products produced and distributed for sterile use.

“Patient safety is a top priority for the agency, and giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Out of an abundance of caution, we are recommending that patients discontinue use of any sterile product produced by this firm.”

As reported by the U.S. Food and Drug Administration, the Specialty Medicine Compounding Pharmacy recalled products that were distributed directly to hospitals and patients located in the state of Michigan between July 1, 2013 and Oct. 19, 2013.

The compounding pharmacy found undetermined particulate matter floating in a sterile product.  The recall was made because this lot may have been administered to patients already in a Michigan hospital.

FDA suggested the following steps be taken if you are a hospital, veterinarian, health care providers and patients that has received ANY sterile product from this compound pharmacy:

  1. Immediately discontinue use
  2. Quarantine all sterile products
  3. Return the recalled products to Specialty Medicine Compounding Pharmacy

The Medical Drug and Device Attorneys at Zoll, Kranz & Borgess, LLC can be contacted for more information.   The toll-free number is 888-841-9623.

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Michelle L. Kranz

Michelle is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has been a plaintiff’s lawyer for the entirety of her practice – over 32 years. She devotes the majority of her time to complex consolidated litigation and class action including advocating for people injured by medical devices, prescription medications, or corporate negligence.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.

Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.

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You can learn more about this topic by visiting any of our Compounding Pharmacy Lawsuits pages listed below:
Abrams Royal Compounding Pharmacy Recalls Products After Adverse Event
Are Specialty Compounded Drugs Safe?
Drug Quality and Security Act Awaiting to be Passed by Senate
Michigan AG Seeks To Tighten Oversight of Compounding Pharmacies
Ohio-Based Pharmacy Recalls Inhaled Drug Solution
Specialty Compounding, LLC Issues Voluntarily Recall
Two Deaths in Texas Related to Specialty Compounding, LLC
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