Slate Run Pharmaceuticals Recalls Eptifibatide Injection Due to Labeling Error

Source: FDA · United States

According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.

Slate Run Pharmaceuticals has issued a voluntary recall for Eptifibatide Injection (75 mg/100 mL) due to a labeling error that misidentifies the product's intended administration method.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Slate Run Pharmaceuticals has initiated a voluntary recall of Eptifibatide Injection, 75 mg/100 mL, due to a labeling discrepancy on the product's carton. The packaging incorrectly states the vial is for "weight-adjusted bolus dosing," while the FDA-approved statement should read "weight-adjusted infusion."

Which Products Are Affected

The recall affects all lots within expiry of the following products:

  • Product Name: Eptifibatide Injection, 75 mg/100 mL vial
  • Slate Run Carton Label: NDC 70436-027-80 (UPC: 0370436027804)
  • ProRx Carton Label: NDC 70436-163-80 (UPC: 0370436163809)
  • Manufacturer: Hainan Poly Pharm. Co., Ltd.
  • Distributor: Slate Run Pharmaceuticals, LLC

This recall applies to distribution nationwide within the United States.

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected NDC numbers listed above. If the mislabeled product is found, contact Slate Run Pharmaceuticals for instructions regarding the return or replacement of the vials. Consumers with questions regarding this recall can contact the firm at their Columbus, Ohio headquarters.

Why This Matters

This is classified as a Class III recall, which indicates that the use of or exposure to the mislabeled product is not likely to cause adverse health consequences, but the labeling error represents a regulatory violation.

Source

Information provided by the FDA under Recall Number D-0343-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Slate Run Pharmaceuticals has issued a voluntary recall for Eptifibatide Injection (75 mg/100 mL) due to a labeling error that misidentifies the product's intended administration method.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.