Provepharm Recalls Phenylephrine Hydrochloride Injection

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Provepharm announced on Jan. 24, 2025 that it has voluntarily recalled one lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) because a customer found a visible black particulate matter in a single-sealed vial. The recalled product is packaged in 10 mL, single-dose vials with national drug code 81284-213-01, lot number 24020027, and an expiration date of December 2025. It was distributed nationwide in the United States.

Phenylephrine hydrochloride Injection is used to treat hypotension resulting from vasodilation in the setting of anesthesia. Injecting product that contains particulates may cause local irritation and swelling.

“If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death,” the company stated in the press release (1).

The company advised wholesalers, distributors, compounders, and hospitals to immediately stop using the product and return it to Provepharm’s recall provider, Sedgwick. While the company states it has not yet received any reports of adverse events associated with the recall, these events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

Packaging problems, such as particulates and defective vials, are a common cause of product recalls. These recalls can be hazardous to the health of patients but can also be expensive for companies to resolve and prevent. In September 2024, Gilead recalled one lot of Veklury (remdesivir) for Injection 100 mg/vial after a customer complaint of a glass particle found in a vial. An investigation performed by the company confirmed the presence of the glass particulate. While at the time of the recall the company had not received reports of any adverse events associated with the recall, if administered, the glass particulate could travel to organs and blood vessels, causing stroke or death.

In an episode of Pharmaceutical Technology®’s Ask the Expert video series, Dirk Margosch, vice president visual inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, discussed steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (3). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences, according to Margosch.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

References

1. FDA. Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter. Press Release. FDA.gov. Jan. 24, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp
2. FDA. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle. Press Release. FDA.gov. Sept. 23, 2024.
3. Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. PharmTech.com. Jan. 23, 2025. https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging