Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Reported: November 27, 2019 Initiated: October 11, 2019 #D-0519-2020
Product Description
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Reason for Recall
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Details
- Recalling Firm
- X-Gen Pharmaceuticals Inc.
- Units Affected
- 25120 vials
- Distribution
- U.S.A. Nationwide
- Location
- Horseheads, NY
Frequently Asked Questions
What product was recalled? ▼
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 25120 vials.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2019. Severity: Low. Recall number: D-0519-2020.
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