Hikma Injectables USA Inc. is recalling 1,800 syringes of Ketamine injection and an unspecified quantity of Phenylephrine injection due to a lack of sterility assurance. The recall was initiated after it was discovered that the tamper-evident seals on several syringes were not attached when the shipments were received. The affected products are compounded drugs intended for hospital or office use only, including Ketamine (50 mg/1 mL) and Phenylephrine (1 mg/10 mL) in pre-filled syringes.
A detached or missing tamper-evident seal compromises the sterile barrier of the syringe. This creates a risk that the medication could be contaminated with bacteria or other harmful pathogens, which can lead to serious or life-threatening infections if the drug is injected into a patient.
Compounded Drug. Hospital/Office Use Only.
Rx only.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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