The Recall Desk
ModerateFDA (Drugs)·D-864-2014·Announced 2014-01-29

Aidapak Recalls CapsuleTOPRIL Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling CapsuleTOPRIL 6.25 mg tablets because they may have been mislabeled as Lubiprostone 24 mcg capsules.

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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a label mixup, which is a significant labeling error but does not involve a direct physical defect or contamination.

Plain-English summary

Aidapak Services, LLC is recalling CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), NDC 00143117101. The recall is due to a labeling error where the product may have been mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060.

The affected product has the pedigree AD46312_4 and an expiration date of 5/16/2014. The potentially mislabeled product has the pedigree AD46312_1 and the same expiration date. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the recalled description, they should contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.

The recalled product

Product
CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.
Affected units
200

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 (4)

  • CapsuleTOPRIL
  • Tablet
  • 6.25 mg (1/2 of 12.5 mg) has the following codes: Pedigree: AD46312_4
  • EXP: 5/16/2014.

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

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