American Health Packaging Recalls Mis-Labeled Ibuprofen Tablets
American Health Packaging is recalling 137,300 Ibuprofen 600 mg tablets because some cartons were mis-labeled as Oxcarbazepine 300 mg.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which is the highest level of recall for serious health hazards.
Plain-English summary
American Health Packaging is recalling 137,300 tablets of Ibuprofen Tablets, USP, 600 mg (NDC 68084-0703-01). The recall involves Lot #142588, which expires in January 2016. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because some cartons containing Ibuprofen 600 mg tablets were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300 mg (Lot #142544). This labeling error could lead to patients receiving the wrong medication.
Consumers and healthcare providers should check their inventory for Ibuprofen Tablets, USP, 600 mg, Lot #142588. If found, the product should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 137,300
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 #142588
- Exp 01/2016
Distribution
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.
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