Why it was recalled
CGMP Deviations
Product description
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Lot numbers, UPCs & expiration codes
All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315
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-1494-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 17, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 1,299 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1494-2016, 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 # 4720915, 6790315, 6800315, 6810315, 6820315
- Postal code
- 19044-1220
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1494-2016
- Classification
- Class II
- Recalling firm
- Teva North America
- Product quantity
- 1,299 bags
- Termination date
- Feb 7, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 17, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2016