Aidapak Recalls Tolterodine Tartrate ER Capsules Due to Labeling Error
Aidapak Services, LLC is recalling Tolterodine Tartrate ER capsules because they may be mislabeled as other medications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Tolterodine Tartrate ER, Capsule, 4 mg, NDC 00009519101. The recall was initiated because the product may be potentially mislabeled as Hydralazine HCL, Tablet, 25 mg, or Prenatal Multivitamin/Multimineral, Tablet.
The recalled Tolterodine Tartrate ER capsules were distributed in Arizona, California, Oregon, and Washington. The affected lots include Pedigree AD49448_1 with an expiration date of 5/17/2014, and Pedigree AD73686_1 with an expiration date of 5/31/2014.
Consumers should check their medication labels and consult their healthcare provider or pharmacist if they have questions about the recall or their medication.
The recalled product
- Product
- TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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 (6)
- TOLTERODINE TARTRATE ER
- Capsule
- 4 mg has the following codes: Pedigree: AD49448_1
- EXP: 5/17/2014
- Pedigree: AD73686_1
- EXP: 5/31/2014.
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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