The Recall Desk
ModerateFDA (Drugs)·D-517-2014·Announced 2014-01-22

Fluoxetine Capsules Recalled Due to Potential Labeling Error

Aidapak Services is recalling Fluoxetine HCl capsules because they may be mislabeled as Pancrelipase DR.

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 illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Fluoxetine HCl Capsules, 10 mg, NDC 16714035103. The recall is due to a labeling error where the product may be mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401.

The affected product has the pedigree AD70585_13 and an expiration date of 5/29/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
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)

  • FLUoxetine HCl
  • Capsule
  • 10 mg has the following code Pedigree: AD70585_13
  • EXP: 5/29/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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