Hyoscyamine Sulfate SL recall: Labeling Error
HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
Why was Hyoscyamine Sulfate SL recalled?
Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN
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 SL, Tablet, 0.125 mg has the following codes: Pedigree: AD21790_19, EXP: 5/1/2014; Pedigree: AD46265_7, EXP: 5/15/2014; Pedigree: W003679, EXP: 6/25/2014; Pedigree: AD60272_16, EXP: 5/22/2014; Pedigree: AD30140_10, EXP: 5/7/2014; Pedigree: W003000, EXP: 6/11/2014; Pedigree: W003326, EXP: 6/19/2014.
- Product
- HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 909 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)