Oxcarbazepine Oral Suspension recall: Impurity Out of Spec
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
Why was Oxcarbazepine Oral Suspension recalled?
Failed Impurities/Degradation Specificattion
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
- Product
- 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
- Recalling firm
- West-Ward Columbus Inc
- Quantity
- 32,347 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- September 25, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)