Hyoscyamine Sulfate ODT recall: Labeling Error
HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701.
Why was Hyoscyamine Sulfate ODT recalled?
Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg has the following codes: Pedigree: W003614, EXP: 6/25/2014.
- Product
- HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 101 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)