Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Man...
FDA Recall #D-0099-2018 — Class II — October 12, 2017
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
Reason for Recall
Presence of foreign substance (screw)
Recalling Firm
Hetero Labs, Ltd. - Unit III — Hyderabad, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4050 bottles
Distribution
NJ
Code Information
Lot # E170346, Exp 02/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated