FDA Recalls Pseudoephedrine Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling pseudoephedrine HCL tablets because they may be mislabeled as d-alpha tocopheryl acetate capsules.
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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Aidapak Services, LLC is recalling Pseudoephedrine HCL, Tablet, 30 mg (NDC 00904505360) due to a labeling mixup. The source text indicates that these tablets may be potentially mislabeled as D-Alpha Tocopheryl Acetate, Capsule, 400 units (NDC 49348041010). The affected product has the pedigree AD52993_37 and an expiration date of 5/20/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, which indicates a situation that might temporarily cause or contribute to reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or the FDA as directed by the recalling firm.
The recalled product
- Product
- PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360
- 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
- 30 mg has the following code Pedigree: AD52993_37
- EXP: 5/20/2014.
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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