Letrozole Tablets Recalled for Potential Mislabeling as Metoprolol Tartrate
Aidapak Services, LLC is recalling Letrozole 2.5 mg tablets that may be mislabeled as Metoprolol Tartrate 50 mg. The error could lead to patients receiving the wrong medication.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as receiving the wrong medication) are rated as Severe (4), as they are not Class I but involve significant risk.
Plain-English summary
Aidapak Services, LLC is recalling Letrozole Tablet, 2.5 mg, NDC 62756051183, due to a labeling mixup. The source text indicates that these tablets may be potentially mislabeled as Metoprolol Tartrate, Tablet, 50 mg, NDC 00093073301. The affected product has the pedigree W003868 and an expiration date of 6/27/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their medication labels to ensure they are receiving the correct drug. If you have received Letrozole tablets that are labeled as Metoprolol Tartrate, or vice versa, contact your pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- LETROZOLE Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756051183
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- LETROZOLE
- Tablet
- 2.5 mg has the following code Pedigree: W003868
- EXP: 6/27/2014.
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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