D-1863-2019 Class II Terminated

Recalled by West-Ward Columbus Inc — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
September 25, 2019
Initiation Date
September 9, 2019
Termination Date
June 15, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,347 bottles

Product Description

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59

Reason for Recall

Failed Impurities/Degradation Specificattion

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020