Sulfasalazine Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling 500 mg sulfasalazine tablets that may be mislabeled as fluconazole or phenytoin sodium.
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 500 mg sulfasalazine tablets (NDC 00603580121) due to a potential labeling mixup. The recalled product may have been mislabeled as fluconazole 200 mg tablets or phenytoin sodium ER 30 mg capsules.
The recall involves repacked drugs distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are listed in the agency notice for the affected lots.
Consumers should check their medication packaging for the specific NDC and pedigree codes listed in the official recall notice. If the product matches the description, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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 (4)
- has the following codes: Pedigree: AD65475_19
- EXP: 5/28/2014
- Pedigree: W003335
- EXP: 6/19/2014.
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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