Sulfasalazine Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Sulfasalazine 500 mg tablets because they may be mislabeled as Hyoscyamine Sulfate 0.125 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 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 mixup without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Sulfasalazine, Tablet, 500 mg (NDC 59762500001) due to a labeling mixup. The recalled product may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg (NDC 00574025001). The specific pedigree for the Sulfasalazine is AD46265_13, and the expiration date is 5/15/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating a situation that might temporarily cause or present a slight probability of serious adverse health consequences.
Consumers and healthcare providers should check their inventory for Sulfasalazine 500 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 questions regarding their medication.
The recalled product
- Product
- sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001
- 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)
- sulfaSALAzine
- Tablet
- 500 mg has the following code Pedigree: AD46265_13
- EXP: 5/15/2014.
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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