Aidapak Recalls Nitrofurantoin Capsules Due to Potential Label Mixup
Aidapak Services, LLC is recalling Nitrofurantoin Macrocrystals capsules because they may be mislabeled as Phytonadione tablets.
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 error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Nitrofurantoin Macrocrystals Capsules, 50 mg, NDC 47781-0307-01. The recall is due to a labeling mixup where the product may be mislabeled as Phytonadione, Tablet, 5 mg, NDC 25010-0405-15.
The affected product is identified by Pedigree AD25452_4 and an expiration date of 5/3/2014. The potentially mislabeled product is identified by Pedigree AD25452_1 and an expiration date of 4/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for the specific Nitrofurantoin Macrocrystals capsules with the pedigree and expiration date listed above. If found, the product should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 102
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)
- NITROFURANTOIN MACROCRYSTALS
- Capsule
- 50 mg has the following code Pedigree: AD25452_4
- EXP: 5/3/2014.
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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