Recalls / Class II
Class IID-1494-2016
Product
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).
- Affected lot / code info
- All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 1,299 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-06-17
- FDA classified
- 2016-09-07
- Posted by FDA
- 2016-09-14
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1494-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.