The Recall Desk
ModerateFDA (Drugs)·D-498-2014·Announced 2014-01-22

FDA Recalls Galantamine Capsules Due to Potential Labeling Error

Aidapak Services is recalling Galantamine HBr ER capsules because they may be mislabeled as Famotidine tablets.

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 mixup without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Galantamine HBr ER, Capsule, 8 mg (NDC 10147089103) due to a labeling error. The recall was initiated because the product may be potentially mislabeled as Famotidine, Tablet, 20 mg (NDC 16714036104). The affected product has the pedigree W003509 and an expiration date of 6/21/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or the recalling firm for proper disposal or credit.

The recalled product

Product
GALANTAMINE HBr ER, Capsule, 8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10147089103
Affected units
30

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)

  • GALANTAMINE HBr ER
  • Capsule
  • 8 mg has the following code Pedigree: W003509
  • EXP: 6/21/2014.

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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