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The Compounding Shop, LLC Recalls All Lots of Compounded Products

En Español

On May 6, 2013, in cooperation with the FDA, The Compounding Shop, LLC voluntarily recalled all lots of sterile products compounded by the pharmacy that were not yet expired. Observations during a recent inspection raised concerns over quality control procedures that may present a risk to sterility assurance.

Response To Recalled Product

Patients are at risk for very serious infections if administered a compromised sterile product. In response to this, The Compounding Shop made the decision to halt the production of sterile products until further notice.

The products were distributed to licensed medical professionals and to patients with prescriptions. The pharmacy notified its customers to return products back to the pharmacy.

Reporting Problems

Patients or providers with inquires may reach The Compounding Shop at 727-381-9799 or toll free 866- 792-6731 (10am-6pm, M-F) or by email to [email protected]ompoundingshop.com.

Adverse reactions or quality problems experienced with the use of any of the recalled drugs may be reported to:

  • Online: http://www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
    http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

 

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