Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

FDA recall notice · announced November 27, 2013 · Boehringer Ingelheim Roxane

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

The product

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

Reason for recall

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Notes

Distribution: Nationwide
Lot/code information: Lot # 161304B, Exp. OCT 2013
Quantity: 10,267 bottles
Status: Terminated
Products in this recall event:
- Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 (D-002-2014)

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