Aidapak Recalls Hyoscyamine Sulfate Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Hyoscyamine Sulfate ER tablets because they may be mislabeled as Sertraline HCL. The error involves a label mixup.
What this means for you
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 (label mixup) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Aidapak Services, LLC is recalling Hyoscyamine Sulfate ER, 0.375 mg tablets (NDC 43199001401) due to a labeling error. The recall is classified as FDA Class II. The specific issue is a label mixup where the Hyoscyamine Sulfate ER tablets may be potentially mislabeled as Sertraline HCL, 50 mg tablets (NDC 16714061204).
The affected product is identified by Pedigree W003576 and an expiration date of 6/24/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of units affected or report any illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for Hyoscyamine Sulfate ER 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
- HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 99
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 (3)
- HYOSCYAMINE SULFATE ER Tablet
- 0.375 mg has the following code Pedigree: W003576
- EXP: 6/24/2014.
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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