Aidapak Recalls Phenobarbital Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Phenobarbital 97.2 mg tablets because they may have been mislabeled as 64.8 mg tablets.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Phenobarbital, Tablet, 97.2 mg (NDC 00603516821) due to a potential label mixup. The recalled product may have been mislabeled as Phenobarbital, Tablet, 64.8 mg (NDC 00603516721). Both products share the same expiration date of May 31, 2014, but have different pedigree codes (AD73518_10 for the recalled 97.2 mg tablets and AD73518_7 for the 64.8 mg tablets).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Each unit contains 100 tablets. This is a prescription-only medication.
Consumers and healthcare providers should check their inventory for Phenobarbital 97.2 mg tablets with NDC 00603516821 and pedigree AD73518_10. If found, they should stop using the product and contact Aidapak Services, LLC for further instructions or a return.
The recalled product
- Product
- PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
- 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)
- PHENobarbital
- Tablet
- 97.2 mg has the following codes: Pedigree: AD73518_10
- 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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