Eptifibatide Injection Labeling Error Recall by Slate Run
Slate Run Pharmaceuticals is recalling Eptifibatide Injection due to a labeling error on the carton, which incorrectly describes the dosing instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The rubric states that FDA Class III recalls are typically scored 1 or 2, and no illnesses or injuries have been reported.
Plain-English summary
Slate Run Pharmaceuticals is recalling Eptifibatide Injection, 75 mg/100 mL vial, due to a labeling error. The carton states '75 mg/100 mL vial for weight-adjusted bolus dosing,' but the approved labeling should read '75 mg/100 mL vial for weight-adjusted infusion.' This discrepancy could lead to incorrect administration of the drug.
The recall affects all lots of Eptifibatide Injection within expiry and is classified as a Class III recall by the FDA, meaning the error is unlikely to cause adverse health consequences. The product is distributed nationwide within the USA.
Healthcare providers and consumers should check their inventory for the affected product. The NDC numbers associated with the recalled product are 70436-027-80 and 70436-163-80. No illnesses or injuries have been reported in connection with this labeling error.
Anyone in possession of the recalled product should contact Slate Run Pharmaceuticals for return or replacement instructions. Consumers should not use the product if the carton labeling does not match the approved infusion dosing instructions.
The recalled product
- Product
- EPTIFIBATIDE (EPTIFIBATIDE)
- Brand
- EPTIFIBATIDE
- Manufacturer
- Slate Run Pharmaceuticals
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
UPCs (2)
- 0370436027804
- 0370436163809
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · EPTIFIBATIDE
- ModerateDrug Recall: Eptifibatide Injection Due to Failed Degradation Specifications
FDA (Drugs) · 2024-06-26
Same manufacturer · Slate Run Pharmaceuticals
See all →- HighCinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits
FDA (Drugs) · 2025-03-26
- HighCinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
FDA (Drugs) · 2025-03-26
Same hazard · mis labeling
See all →- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02