The Recall Desk
ModerateFDA (Drugs)·D-780-2014·Announced 2014-01-29

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 Ranolazine ER or Ferrous Sulfate.

What this means for you

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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.

Plain-English summary

Aidapak Services, LLC is recalling Tolterodine Tartrate ER, Capsule, 2 mg (NDC 00009519001) due to a labeling error. The recalled product may be mislabeled as Ranolazine ER, Tablet, 500 mg (NDC 61958100301) or Ferrous Sulfate, Tablet, 325 mg (NDC 00904759160).

The affected Tolterodine Tartrate ER capsules are 60-count packages with the following pedigree and expiration codes: Pedigree AD65478_1, EXP 5/29/2014; and Pedigree W002724, EXP 6/6/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific codes and stop using the product if it matches the description. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.
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
  • 2 mg has the following codes: Pedigree: AD65478_1
  • EXP: 5/29/2014
  • Pedigree: W002724
  • EXP: 6/6/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →