Levetiracetam Solution
FDA Recall NDC 31722-574
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Levetiracetam (NDC 31722-574). A significant event, classified as Class II, was initiated on Oct 12, 2017 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of foreign substance (screw)"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign substance (screw)
Oct 12, 2017
Dec 06, 2017
4050 bottles
Recall Profile & Regulatory Data
Event ID
78287
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ
Termination Date
Sep 03, 2020
Product Description
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
Batch or Lot Expiration Information
Lot# E170346, Exp 02/19
Affected Packages Involved in this Recall
31722-574-47Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
