Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
10 FDA recalls mention Oxcarbazepine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxcarbazepine.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Presence of foreign substance
Reason Failed Impurities/Degradation Specificattion
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets…
Reason Failed Tablet Specifications: Broken Tablets Present.
Reason Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree…
Reason Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree…
Reason Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Reason SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight…
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