Tolterodine Tartrate ER recall: Labeling Error
TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
Why was Tolterodine Tartrate ER recalled?
Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 mg, NDC 51991056601, Pedigree: AD73597_1, EXP: 5/31/2014.
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?
TOLTERODINE TARTRATE ER, Capsule, 4 mg has the following codes: Pedigree: AD49448_1, EXP: 5/17/2014; Pedigree: AD73686_1, EXP: 5/31/2014.
- Product
- TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 60 Capsules
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)