FDA Recalls Phenobarbital Tablets Due to Potential Pregabalin Labeling Error
Aidapak Services is recalling Phenobarbital tablets that may be mislabeled as Pregabalin capsules. The error poses a risk of patients receiving the wrong medication.
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 with potential for significant harm (such as medication mix-ups) are categorized as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Phenobarbital, Tablet, 64.8 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the product may have been mislabeled as Pregabalin, Capsule, 200 mg.
The affected product is identified by NDC 00603516721, with pedigree AD73518_7 and an expiration date of 5/31/2014. The potentially mislabeled product is identified by NDC 00071101768, with pedigree AD73518_4 and an expiration date of 5/31/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should verify the medication label against the prescription. If the label indicates Pregabalin but the patient was prescribed Phenobarbital, or vice versa, they should contact their pharmacist or healthcare provider immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- PHENobarbital
- Tablet
- 64.8 mg has the following codes: Pedigree: AD73518_7
- EXP: 5/31/2014.
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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