Specialty Compounding Extends Recall; Public Citizen Blasts FDA
More questions arise as investigations into the outbreak of blood stream infections in Corpus Christ, Texas hospitals continue.
Specialty Compounding Extends Sterile Product Recall
- Specialty Compounding originally recalled all unexpired sterile products shipped from May 9, 2013- August 9, 2013.
- This was done in response to a series of blood stream infections caused by Rhodococcus equi in Corpus Christi patients who were receiving calcium gluconate treatment produced by the compounding pharmacy.
- So far, there have been at least 17 reports of infection and 4 deaths associated with the outbreak.
- Specialty Compounding has expanded its recall to products shipped before May 9. This may be due in part to a FDA Form 483 which was issued to the company in March that cited “significant objectionable conditions” in its facility near Austin, Texas.
Public Citizen Blasts Lack of Action by FDA
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected.” Michael Carome, MD in Public Citizen Press Release
- Public Citizen has begun to question why the FDA did not pursue action against Specialty Compounding, LLC when it discovered the objectionable conditions cited in the FDA Form 483.
- According to the Public Citizen, the FDA cited similar conditions at 50 other compounding pharmacies nationwide, but only 16 of these companies have issued recalls.
- The FDA has said that its authority over compounding pharmacies is “limited, unclear, and contested” and congress is currently considering a bill that would resolve the confusion.
- Currently, most compounding pharmacy regulation is done at the state level, but, according to MedPage, the Texas Department of State Health Services claims it did not receive the FDA Form 483 issued to Specialty Compounding until nearly four months after its insuance.
- Further, while the original FDA releases stated that the calcium gluconate and other sterile products had only been shipped to Texas, Specialty Compounding has indicated that sterile products were also sent directly to patients nationwide (excluding North Carolina).
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