The Recall Desk
ModerateFDA (Drugs)·D-785-2014·Announced 2014-01-29

Aidapak Recalls Pancrelipase DR Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling Pancrelipase DR capsules because they may be mislabeled as other prescription drugs. The affected repacked drugs were distributed in four western states.

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 (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Pancrelipase DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, due to a labeling error. The recall is initiated because the capsules may be potentially mislabeled as other prescription medications, including Sertraline HCL, Thyroid, Cholecalciferol, or Amlodipine.

The recalled product consists of 498 capsules per unit. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are listed in the official recall notice.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the medication. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032122401.
Affected units
498

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)

  • PANCRELIPASE DR
  • Capsule
  • 24000 /76000 /120000 USP units has the following codes: Pedigree: AD70585_10
  • EXP: 5/29/2014 Pedigree: W002850
  • EXP: 6/7/2014
  • Pedigree: W003856
  • EXP: 6/26/2014 Pedigree: AD65457_4
  • EXP: 5/24/2014
  • Pedigree: AD70655_1
  • EXP: 5/28/2014.

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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