Minoxidil Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Minoxidil 2.5 mg tablets because they may have been mislabeled as methylprednisolone 4 mg.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Minoxidil, Tablet, 2.5 mg, NDC 00591564201. The recall was initiated because the medication may have been mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201. The affected Minoxidil tablets have the pedigree AD52778_49 and an expiration date of 5/20/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.
The recalled product
- Product
- MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591564201.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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)
- MINOXIDIL
- Tablet
- 2.5 mg has the following codes: Pedigree: AD52778_49
- EXP: 5/20/2014.
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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