Mirtazapine Tablets Recalled for Potential Mislabeling as Isoniazid
Aidapak Services is recalling Mirtazapine 7.5 mg tablets that may be mislabeled as Isoniazid 300 mg. The error poses a risk of incorrect medication administration.
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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are categorized as Severe.
Plain-English summary
Aidapak Services, LLC is recalling Mirtazapine Tablet, 7.5 mg, Rx only, NDC 59762141509. The recall is due to a labeling mixup where the product may be potentially mislabeled as Isoniazid, Tablet, 300 mg, NDC 00555007102. The affected Mirtazapine tablets have the pedigree W003693 and an expiration date of 4/30/2014. The potentially mislabeled Isoniazid tablets have the pedigree W003691 and an expiration date of 6/26/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should check their inventory for Mirtazapine 7.5 mg tablets with the specified pedigree and expiration date. If found, these products should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken a medication that may have been mislabeled.
The recalled product
- Product
- MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141509
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 90
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)
- MIRTAZAPINE
- Tablet
- 7.5 mg has the following code Pedigree: W003693
- EXP: 4/30/2014.
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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