PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 25, 2019 Initiated: September 9, 2019 #D-1863-2019

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

Details

Recalling Firm
West-Ward Columbus Inc
Units Affected
32,347 bottles
Distribution
Nationwide USA and Puerto Rico
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by West-Ward Columbus Inc. Units affected: 32,347 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specificattion
Which agency issued this recall?
This recall was issued by the FDA Drug on September 25, 2019. Severity: Moderate. Recall number: D-1863-2019.