Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Errors
Aidapak Services is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The affected repacked drugs were distributed in four western states.
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, which typically involves a labeling error that could cause temporary or medically reversible health consequences. The source describes a 'Label Mixup' without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Phytonadione Tablet, 5 mg, NDC 25010040515, due to a labeling error. The source text indicates that the Phytonadione tablets may be potentially mislabeled as medroxyPROGESTERone ACETATE, HYDROCORTISONE, GALANTAMINE HBR ER, or TORSEMIDE.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves 500-tablet units with specific pedigree codes and expiration dates ranging from April 30, 2014, to May 31, 2014.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed in the recall notice. If the product is found, it should be returned to the distributor or the FDA.
The recalled product
- Product
- PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 500
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 (9)
- PHYTONADIONE Tablet
- 5 mg has the following codes Pedigree: AD46312_22
- EXP: 4/30/2014
- Pedigree: W003061
- EXP: 5/31/2014
- Pedigree: W003737
- Pedigree: AD25452_1
- Pedigree: W003440
- EXP: 5/31/2014.
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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