Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Reported: September 14, 2016 Initiated: June 17, 2016 #D-1497-2016
Product Description
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Teva North America
- Units Affected
- 13,223 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton). Recalled by Teva North America. Units affected: 13,223 vials.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1497-2016.
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