Hyoscyamine Sulfate Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Hyoscyamine Sulfate ODT tablets that may have been mislabeled as Fluoxetine HCl capsules.
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 due to a labeling error (label mixup) which is a minor labeling issue that may cause temporary adverse health consequences but is not a Class I hazard.
Plain-English summary
Aidapak Services, LLC is recalling Hyoscyamine Sulfate ODT, Tablet, 0.125 mg, NDC 00574024701. The recall was initiated because the product may have been mislabeled as Fluoxetine HCl, Capsule, 10 mg, NDC 16714035103. The affected product has the pedigree W003614 and an expiration date of 6/25/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it 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 ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 101
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)
- HYOSCYAMINE SULFATE ODT
- Tablet
- 0.125 mg has the following codes: Pedigree: W003614
- EXP: 6/25/2014.
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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