Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distribut...
FDA Recall #D-0155-2018 — Class II — December 4, 2017
Product Description
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
Reason for Recall
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Recalling Firm
Solco Healtcare US LLC — Cranbury, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Product was distributed in Mason, OH.
Code Information
Lot # 7700656A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated