Raloxifene HCL Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Raloxifene HCL tablets due to a potential label mixup with Isosorbide Mononitrate.
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, which aligns with the 'Moderate' severity criteria for minor labeling errors.
Plain-English summary
Aidapak Services, LLC is recalling Raloxifene HCL, Tablet, 60 mg (NDC 00002416530) due to a potential label mixup. The recalled product may be mis-labeled as Isosorbide Mononitrate, Tablet, 20 mg (NDC 62175010701).
The affected Raloxifene HCL tablets have the pedigree W002644 and an expiration date of 6/5/2014. The potentially mis-labeled Isosorbide Mononitrate tablets have the pedigree W002656 and an expiration date of 6/4/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for these specific pedigree and expiration codes. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- RALOXIFENE HCL, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002416530.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30
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)
- RALOXIFENE HCL
- Tablet
- 60 mg has the following codes: Pedigree: W002644
- EXP: 6/5/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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