The Recall Desk
ModerateFDA (Drugs)·D-469-2014·Announced 2014-01-22

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.

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 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
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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