Pharmedium Recalls Superpotent Phenylephrine Syringes Nationwide

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 2,390 syringes of Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride. The product is identified by NDC 71019-263-20, Lot # 172560019M, and an expiration date of 12/13/2017. The recall was initiated on September 26, 2017, and the affected units were distributed nationwide within the United States.

The FDA classified this recall as Class II because the product was identified as a "Superpotent Drug." A Class II recall indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall was initiated by the firm and was terminated on May 7, 2020.

Healthcare providers and patients who have this specific lot of Phenylephrine HCL should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. The recall was communicated via telephone.

The recalled product

Product

Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20

Manufacturer

Pharmedium Services, LLC

Category

Drug — Injectable

Hazard

• superpotent-drug

Affected units

2,390

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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