Sotalol HCL recall: Labeling Error
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
Why was Sotalol HCL recalled?
Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.
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?
SOTALOL HCL, Tablet, 80 mg has the following codes: Pedigree: AD30993_17, EXP: 5/9/2014; Pedigree: AD52778_85, EXP: 5/21/2014.
- Product
- SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 202 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)