Class II · Moderate risk
Oxcarbazepine Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Oxcarbazepine Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specificattion
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What 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
Affected NDC
0054-0199-59
Compare with the code on your package — it is the most precise check available.
Drug: Oxcarbazepine
- Recalling firm
- West-Ward Columbus Inc
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1863-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxcarbazepine recalls
See all
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Oxcarbazepine active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class I · High risk
Oxcarbazepine Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Other recalls by West-Ward Columbus Inc
All 2019 recalls
Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class III · Low risk
Ethacrynic Acid Tablets USP
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
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