Agency classClass IIOur severity:Moderate FDA (Drugs)·D-485-2014·Announced 2014-01-22

Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling 1,199 tablets of Cholecalciferol 400 units because they may be mislabeled as other medications.

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, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling 1,199 tablets of Cholecalciferol, 400 units, Over The Counter (NDC 00904582360). The recall is due to a labeling mixup where the product may be potentially mislabeled as Cyanocobalamin 500 mcg, Rosuvastatin Calcium 5 mg, or Pyridoxine HCl 100 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected Cholecalciferol tablets, including codes such as AD37056_13, W002574, and AD76686_7.

Consumers should check their medication labels to ensure they are not holding the affected Cholecalciferol tablets with the listed pedigree codes. If the product is found, consumers should stop using it and contact their pharmacist or the recalling firm for instructions.

The recalled product

Product: CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
Affected units: 1,199

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 (20)

CHOLECALCIFEROL
Tablet
400 units has the following codes Pedigree: AD37056_13
EXP: 5/10/2014
Pedigree: W002574
EXP: 6/3/2014
Pedigree: AD76686_7
EXP: 5/31/2014
Pedigree: AD60578_27
EXP: 5/29/2014
Pedigree: W003540
EXP: 6/21/2014
Pedigree: AD52993_25
EXP: 5/20/2014
Pedigree: W002715
EXP: 6/5/2014
Pedigree: AD30197_31
EXP: 5/9/2014
Pedigree: AD73592_8
Pedigree: W002642

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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Same hazard · mis labeling