Medication Recall Due to Contamination with Glass Particles

Medication Recall Due to Contamination with Glass Particles
Medication Recall Due to Contamination with Glass Particles

Auromedics is at the heart of yet another recall scandal after glass particles were found in their Ampicillin and Sulbactam for Injection USP 1.5 g/ vials. The glass particles were too small to be clearly visible to the eye from a distance, but posed a significant risk to patients injected with them.

Key Facts

• The presence of glass particles in a vial designed for injectable medications could potentially result in irritation, swelling, or even infection at the injection site. There is also a potential risk for death if the microscopic shards enter the bloodstream. Blood clots, internal bleeding, and venous blockages are also a risk.

• This particular recall is pre-emptive; there have been no specific incidents reported. Auromedics chose to recall the injectables anyway.

• Both Ampicillin and Sulbactam are antibiotics; the first, Ampicillin, is a penicillin-derived broad-spectrum antibiotic, while the other is a β-lactamase inhibiting antibiotic. The two are often given together to fight tough infections.

• The fact that these injectables are designed for advanced infections makes the recall particularly concerning. Patients suffering from illnesses like advanced Staphylococcus or Streptococcus diseases are already in an immunocompromised state. To introduce a potentially volatile foreign compound could theoretically cause a catastrophic advancement of illness.

• This is the third in a recent series of recalls suffered by Auromedics. Previous recalls include a Linezolid Injection recall for injectables containing mold and a Pantoprazole Sodium injection that also contained glass particles.

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