The Recall Desk
ModerateFDA (Drugs)·D-963-2014·Announced 2014-01-29

Aidapak Recalls Estropipate Tablets Due to Potential Labeling Error

Aidapak Services is recalling Estropipate 0.75 mg tablets because they may have been mislabeled as Mesalamine DR 400 mg 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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Estropipate 0.75 mg tablets (NDC 00591041401) due to a potential labeling error. The affected tablets may have been mislabeled as Mesalamine DR 400 mg capsules (NDC 00430075327).

The recall involves repacked drugs distributed in Arizona, California, Oregon, and Washington. The specific product code is Pedigree AD34934_4 with an expiration date of 5/10/2014. The mislabeled product code is Pedigree AD34934_1 with an expiration date of 1/31/2014.

Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the 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
ESTROPIPATE, Tablet, 0.75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591041401.
Affected units
100

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)

  • ESTROPIPATE
  • Tablet
  • 0.75 mg has the following codes: Pedigree: AD34934_4
  • EXP: 5/10/2014

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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