FDA Recalls Phenobarbital Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Phenobarbital tablets that may have been mislabeled as Efavirenz capsules. The error involves a label mixup during repacking.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential mislabeling of prescription drugs which could lead to incorrect dosing or treatment.
Plain-English summary
Aidapak Services, LLC is recalling Phenobarbital, Tablet, 97.2 mg, NDC 00603516832, due to a potential labeling error. The FDA has identified that these tablets may have been mislabeled as Efavirenz, Capsule, 200 mg, NDC 00056047492. This is classified as a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences.
The affected product is a prescription-only medication distributed by Aidapak Services, LLC. The specific pedigree for the recalled Phenobarbital is AD46339_1 with an expiration date of 5/16/2014. The potentially mislabeled Efavirenz product has pedigree AD46312_31 and the same expiration date. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should verify the labeling of their medications. If you have Phenobarbital tablets with the specified pedigree and expiration date, contact your pharmacist or healthcare provider for guidance on whether to return the product or obtain a replacement. Do not take the medication if you are uncertain about its identity.
The recalled product
- Product
- PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,000
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)
- PHENobarbital
- Tablet
- 97.2 mg has the following codes: Pedigree: AD46339_1
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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