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

FDA recall notice · announced September 25, 2019 · West-ward Columbus

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Impurities/Degradation Specificattion

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
Quantity: 32,347 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1863-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.