CLASS II Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled
Teva North America is recalling Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial, For Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 17 Jun 2016 and the FDA has classified it as Class II.
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-1496-2016
- FDA event ID
- 74497
- Recalling firm
- Teva North America, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2016
- FDA classified
- 7 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Jun 2016 | Recall initiated by company | |
| 7 Sep 2016 | Classified by FDA | +82 days |
| 14 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
3 other products · FDA event 74497This product is part of a recall event; the main page for the event is Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Teva North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 400 mg recalledAmoxicillin | Teva North America | 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, a) 20 mg/ (2 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 |