CLASS III Drug recall · Reported 4 Sep 2019 · FDA Enforcement Report
Eptifibatide Injection, a) 20 mg/ (2 mg/mL) Single Use Vial recalled
Akorn is recalling Eptifibatide Injection, a) 20 mg/ (2 mg/mL) Single Use Vial, distributed nationwide in the US. The recall was initiated on 6 Aug 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1841-2019
- FDA event ID
- 83497
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Aug 2019
- FDA classified
- 23 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Aug 2019 | Recall initiated by company | |
| 23 Aug 2019 | Classified by FDA | +17 days |
| 4 Sep 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Which lots are affected?
Lot #s: a) 091307A, Exp. 9/19; 101097A, Exp. 10/19; b) 091277A, Exp. 9/19.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 83497This product is part of a recall event; the main page for the event is Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide | |
| CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Eptifibatide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ vial recalledEptifibatide | Slate Run Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Eptifibatide injection 20mg/ (2mg/mL) Single-Dose Vial recalledEptifibatide | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ (0.75 mg/mL) Single-use Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |