The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1590-2014·Announced 2014-09-24

Oxcarbazepine Tablets Recalled Due to Labeling Error

American Health Packaging is recalling Oxcarbazepine Tablets due to a label mix-up with Ibuprofen tablets.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which per the rubric mandates a score of at least 4 due to the potential for serious adverse health consequences from taking the wrong medication.

Plain-English summary

American Health Packaging is recalling Oxcarbazepine Tablets, 300 mg, NDC 62584-143-01, Lot #142544. The recall was initiated because some cartons were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544, while the cartons actually contained AHP Ibuprofen Tablets, USP, 600mg, lot #142588.

The affected product was distributed nationwide and in Puerto Rico. The recall involves 59,200 tablets. The agency has classified this recall as Class I.

Consumers should check their medication for the specific lot number and expiration date listed in the recall notice. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
Manufacturer
American Health Packaging
Category
Drug — Prescription Medication
Hazard
Affected units
59,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #142544
  • Exp 02/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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