The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-582-2014·Announced 2014-01-22

Aspirin Tablets Recalled for Potential Mislabeling as Cholecalciferol

Aidapak Services is recalling Aspirin tablets that may be mislabeled as Cholecalciferol. The FDA classifies this as a Class II recall.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential mislabeling of distinct drug products which can lead to incorrect dosing or treatment.

Plain-English summary

Aidapak Services, LLC is recalling 300-tablet bottles of ASPIRIN Tablet, 325 mg, Over The Counter (NDC 4934800123). The recall is due to a labeling error where the product may be mislabeled as CHOLECALCIFEROL, Tablet, 400 units (NDC 00904582360). The affected product has the pedigree code W002640 and an expiration date of 6/4/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that 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 code listed above. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or replacement.

The recalled product

Product
ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348000123
Manufacturer
Aidapak Services, LLC
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
300

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)

  • ASPIRIN
  • Tablet
  • 325 mg has the following code Pedigree: W002640
  • EXP: 6/4/2014.

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 →

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