Aidapak Recalls Mirtazapine Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Mirtazapine 7.5 mg tablets because they may be mislabeled as other prescription 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a labeling mixup where a prescription drug may be misidentified as other distinct medications, creating a risk of incorrect dosing or treatment, which aligns with the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Mirtazapine 7.5 mg tablets (NDC 59762141503) due to a labeling mixup. The affected tablets may be incorrectly labeled as Bromocriptine Mesylate 2.5 mg, Duloxetine HCl DR 20 mg, or Carbamazepine ER 100 mg.
The recalled product consists of 91-tablet packages distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are AD73525_55 (EXP: 5/30/2014), W003012 (EXP: 6/11/2014), and W003334 (EXP: 6/18/2014).
Consumers should check their medication packaging for the NDC 59762141503 and the specific pedigree codes listed above. If the medication matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 91
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 (8)
- MIRTAZAPINE
- Tablet
- 7.5 mg has the following codes Pedigree: AD73525_55
- EXP: 5/30/2014
- Pedigree: W003012
- EXP: 6/11/2014
- Pedigree: W003334
- EXP: 6/18/2014.
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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