The Compounding Shop of St. Petersburg issues recall of all sterile products
On the advice of the Food and Drug Admnistration (FDA), a St. Petersburg, FL pharmacy has issued a recall of all it’s sterile products, according to an FDA news release yesterday.
Based on preliminary findings of an inspection of The Compounding Shop located on Park Avenue, concerns were raised about a lack of sterility assurance for sterile drugs produced at and distributed from this site.
The risk associated with a drug labeled as sterile, which is microbially contaminated, puts patients in danger of serious infections.
The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.
The FDA is advising health care providers and hospital staff to immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products.
Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.
About one year ago in Ocala, Franck’s Compounding Pharmacy issued a recall on all human and veterinary sterile products after mold was detected in their clean rooms.
And of course there was the case of the fungal meningitis outbreak linked to the use of injectable steroids from the New England Compounding Center (NECC) in Massachusetts, where hundreds were infected from contaminated sterile drugs.
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