October 2017 FDA Recall Levetiracetam by Hetero Labs, Ltd. - Unit Iii (D-0099-2018 - Presence of foreign substance (screw))

This Class II drug recall was voluntarily initiated by Hetero Labs, Ltd. - Unit Iii on October 12, 2017 for the product Levetiracetam. The FDA reported the reason for recall as presence of foreign substance (screw). The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0099-2018

Reason for Recall
Presence of foreign substance (screw)
Initiated
10-12-2017
Reported
12-06-2017
Quantity
4050 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78287
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-03-2020
Product Description About Product Description
Full technical description of the product.
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

31722-574-47 Levetiracetam