The Recall Desk
SevereFDA (Drugs)·D-795-2014·Announced 2014-01-29

Aidapak Recalls Acarbose Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Acarbose 25 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant harm (such as receiving the wrong prescription medication) are categorized as Severe.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Acarbose, Tablet, 25 mg, NDC 00054014025, due to a labeling error. The recall is classified as FDA Class II, indicating a situation that might temporarily cause or contribute to reversible adverse health consequences.

The specific hazard is a label mixup where the Acarbose tablets may be mislabeled as other prescription medications, including Zinc Gluconate, Tolterodine Tartrate ER, Sildenafil Citrate, or Sevelamer Carbonate. This mislabeling could lead to patients receiving the wrong medication.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Affected lots include pedigree codes AD60272_1, W002725, W003673, and W002996, with expiration dates ranging from May 22, 2014, to June 25, 2014. Patients and healthcare providers should check their medication labels and contact their pharmacist or the recalling firm if they have questions about the specific products in their possession.

The recalled product

Product
ACARBOSE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054014025.
Affected units
399

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 (10)

  • ACARBOSE
  • Tablet
  • 25 mg has the following codes: Pedigree: AD60272_1
  • EXP: 5/22/2014
  • Pedigree: W002725
  • EXP: 6/6/2014
  • Pedigree: W003673
  • EXP: 6/25/2014
  • Pedigree: W002996
  • EXP: 6/11/2014.

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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