X-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert
X-Gen Pharmaceuticals is recalling Levetiracetam Injection vials because the incorrect package insert version was attached to the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials. The recall was initiated because the incorrect package insert version was attached to the product.
The affected product is identified by NDC 39822-4000-1. The recall includes 25,120 vials distributed nationwide in the U.S.A. The specific lots affected are 7603333, 7603334, 7603335 (Exp 05/2020) and 7051107 (Exp 01/2022). The product was manufactured by Agile Specialties Private Limited in India for X-Gen Pharmaceuticals Inc.
Consumers and healthcare providers should check their inventory for the affected NDC and lot numbers. If the product is found, it should be returned to the distributor or the recalling firm. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 25,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 7603333
- 7603334
- 7603335
- Exp 05/2020
- 7051107
- Exp 01/2022
Distribution
Distributed nationwide across the United States.
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