Recall initiated for phenylephrine hydrochloride injection due to potential foreign material

Phenylephrine hydrochloride injection recall overview: 

• Who: Provepharm issued a recall for one lot of its phenylephrine hydrochloride injection.
• Why: The recall was initiated over concerns the drug may be contaminated with foreign material.
• Where: The recall was issued to the hospital/institutional level. 

Provepharm Inc. issued a recall for one lot of its phenylephrine hydrochloride injection over concerns it may be contaminated with foreign material. 

The recall involves phenylephrine hydrochloride Injection USP 10 mg/mL with an expiration date of December 2025 and lot number 24020027. 

Provepharm said it initiated the recall after a pharmacy informed the company that it observed a “visible black particulate matter” found in a single-sealed vial of the phenylephrine hydrochloride injection drug. 

“Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material,” the recall says. 

Phenylephrine hydrochloride injection treats ‘clinically important’ hypotension 

The recalled drug is used to treat “clinically important” hypotension primarily occurring due to vasodilation in the setting of anesthesia, according to the recall. 

The phenylephrine hydrochloride injection recall is to the hospital/institutional level. Distributors, wholesalers, compounding companies and hospitals are advised to immediately stop using the drug and to return it to Provepharm’s recall provider, Sedgwick. 

Consumers are advised to contact their physician or healthcare provider if they experience any problems that may be related to the recalled phenylephrine hydrochloride injection drug.

In October 2023, Exela issued a recall for several lots of sodium bicarbonate injection under the Exela and Civica brands and cysteine hydrochloride injections under the Midazolam and ELCYS brands after silicone particulate matter was found in the drugs during a routine inspection. 

Are you affected by the phenylephrine hydrochloride injection recall? Let us know in the comments.

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