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Compounding Pharmacy and FDA Issue Drug Recall

Another Compounding Pharmacy Faces Drug Recall

compounding pharmacyThe FDA has alerted hospitals, healthcare professionals, and patients that the Abrams Compounding Pharmacy, in Dallas, TX, has issued a voluntary drug recall for injectable medications, IV injections, eye drops, nasal sprays, inhalation solutions, eye ointments, and pellet implants.

The compounds under the drug recall were manufactured between June 17th and December 17th, 2013.

“Patient safety is our top priority, and giving a patient a contaminated drug could result in a serious infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Using these products puts patients at an unacceptable risk, and we urge health care professionals to follow recall instructions issued by the firm.”

The FDA is aware of one adverse event associated with the contaminated compounds, leading to the drug recall. A California patient was admitted to a hospital and the patient’s blood cultures tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections including pneumonia and meningitis.

After testing, Abrams identified a similar gram-negative bacterium contagion in the same mineral IV injection.

Abrams Compounding Pharmacy issued the drug recall in an abundance of caution, as compounding pharmacies have come under fire lately for unsafe practices. The most notorious such case in November 2012 led to hundreds of patients who received spinal steroid injections developing fungal meningitis.

The outbreak of fungal meningitis was tied directly to the NECC, which, like many compounding pharmacies, had been skirting the law by making large, unregulated batches of drugs. The Centers for Disease Control found that injectable steroids at the compounding pharmacy were visibly tainted – investigations found that the Massachusetts-based company was not leaving enough time for proper sterilization of their products – the investigators found “dirty mats and hoods, a leaky boiler, dark debris floating in vials of medicine.” The steroids, made to be injected into the spine, caused non-contagious fungal meningitis that sickened 751 people across the US, and eventually killed 64 patients.

The Drug Quality and Security Act was signed into law on November 27th, 2013.

Concerned customers can contact their physician with questions and to return any unused product. If patients experience any adverse side effects, they should contact their doctor immediately.

The Strom Law Firm Can Help with Personal Injury Claims from Dangerous Drug Recalls

If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, you may be entitled to file a personal injury lawsuitDefective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work. You will face mounting medical bills as you seek treatment for another’s mistake. The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800



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