Why it was recalled
CGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1496-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 17, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 14,661 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1496-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74497
- Address
- 425 Privet Rd
- Code information
- All Lots Within Expiry Lot# 2710715, 2720715, 2730715, 3110715, 3120715
- Postal code
- 19044-1220
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1496-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 14,661 vials
- Termination date
- Feb 7, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 17, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2016