Aidapak Recalls OXcarbazepine Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling OXcarbazepine 150 mg tablets because they may be mislabeled as traZODone HCl 50 mg.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a potential mislabeling of prescription medications that could lead to adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling OXcarbazepine Tablet, 150 mg, NDC 62756018388, due to a potential labeling mixup. The recalled product may be mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301. The affected lot has the pedigree AD54562_4 and an expiration date of 5/20/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for OXcarbazepine 150 mg tablets with the specified pedigree and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018388
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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 (4)
- OXcarbazepine
- Tablet
- 150 mg has the following code Pedigree: AD54562_4
- EXP: 5/20/2014.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC 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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