Aidapak Recalls Phenobarbital Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Phenobarbital/Hyoscyamine/Atropine/Scopolamine tablets because they may be mislabeled as Valsartan. The repacked drugs were distributed in four western states.
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, which typically involves a labeling error that could cause temporary or medically reversible health consequences. The rubric maps minor labeling errors and low-risk contamination to a Moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling specific repacked tablets of Phenobarbital/Hyoscyamine/Atropine/Scopolamine (16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg) due to a labeling mixup. The agency identified that these prescription-only tablets may be potentially mislabeled as Valsartan, Tablet, 160 mg (NDC 00078035934).
The affected product is identified by Pedigree W003640 and an expiration date of 6/25/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for the specific pedigree and expiration date listed above. If the product matches the description, it should be returned to the pharmacy or distributor for a refund or replacement, as per standard recall procedures.
The recalled product
- Product
- PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510
- Manufacturer
- Aidapak Services, LLC
- 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 (3)
- PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE
- Tablet
- EXP: 6/25/2014.
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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