FDA Recalls Pseudoephedrine Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Pseudoephedrine HCL 60 mg tablets because they may be mislabeled as Repaglinide 1 mg tablets.
What this means for you
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 Pseudoephedrine HCL, Tablet, 60 mg (NDC 00904512559) due to a labeling error. The product may be potentially mislabeled as Repaglinide, Tablet, 1 mg (NDC 00169008281). The affected product has the pedigree W002856 and an expiration date of 6/7/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, which means use of, or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559
- 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)
- PSEUDOEPHEDRINE HCL
- Tablet
- 60 mg has the following code Pedigree: W002856
- EXP: 6/7/2014.
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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