Methylprednisolone Tablets Recalled for Potential Labeling Mixup
Aidapak Services, LLC is recalling methylprednisolone tablets that may have been mislabeled as omeprazole/sodium bicarbonate capsules.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling methylprednisolone tablets, 4 mg, NDC 00603459321. The recall was initiated because the tablets may have been mislabeled as omeprazole/sodium bicarbonate capsules, 20 mg/110 mg, NDC 11523726503.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree for the potentially mislabeled product is AD42584_15 with an expiration date of 5/14/2014.
Consumers should check their medication for the NDC 00603459321 and contact their healthcare provider or pharmacist if they have questions regarding the recall.
The recalled product
- Product
- methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603459321.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- Affected units
- 299
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 (7)
- methylPREDNISolone
- Tablet
- Capsule
- 20 mg/110 mg
- NDC 11523726503
- Pedigree: AD42584_15
- EXP: 5/14/2014.
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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