Aidapak Recalls Mislabeled Methylprednisolone Tablets
Aidapak Services, LLC is recalling methylprednisolone tablets that may have been mislabeled as levothyroxine, nabumetone, or cholecalciferol.
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, which corresponds to a Severe severity score per the rubric, as it involves a labeling error that could lead to serious temporary or medically reversible health consequences.
Plain-English summary
Aidapak Services, LLC is recalling methylprednisolone tablets, 4 mg, NDC 00781502201, due to a potential label mixup. The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington.
The recall is issued because the methylprednisolone tablets may have been mislabeled as one of three other medications: levothyroxine sodium tablets, 112 mcg; nabumetone tablets, 500 mg; or cholecalciferol tablets, 2000 units. Specific pedigree codes and expiration dates are associated with the affected lots.
Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received the affected product. Consumers should not take the medication if they are unsure of its identity.
The recalled product
- Product
- methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 300
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)
- methylPREDNISolone
- Tablet
- 4 mg has the following codes: Pedigree: AD52778_43
- EXP: 5/20/2014
- Pedigree: AD46426_10
- EXP: 5/15/2014
- Pedigree: AD54587_7
- EXP: 5/21/2014.
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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