The Recall Desk
ModerateFDA (Drugs)·D-577-2014·Announced 2014-01-22

Nitrofurantoin Capsules Recalled for Potential Mislabeling as Minocycline

Aidapak Services is recalling Nitrofurantoin capsules that may be mislabeled as Minocycline. The error could lead to patients receiving the wrong medication.

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 that could lead to the administration of the wrong drug. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is recalling Nitrofurantoin Monohydrate/Macrocrystals Capsules, 100 mg, NDC 47781030301. The recall is due to a labeling error where these capsules may be mislabeled as Minocycline HCl Capsules, 50 mg, NDC 00591569401. The affected product has the pedigree AD52778_58 and an expiration date of 5/20/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk because patients may receive Minocycline instead of Nitrofurantoin, or vice versa, depending on how the mislabeled product is dispensed. Receiving the incorrect antibiotic can result in treatment failure or adverse drug reactions.

Healthcare providers and patients should check their medication labels and pedigree codes. If you have Nitrofurantoin capsules with pedigree AD52778_58, do not use them and contact your pharmacist or healthcare provider for instructions on how to return the product.

The recalled product

Product
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030301
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)

  • NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS
  • Capsule
  • 100 mg has the following code Pedigree: AD52778_58
  • EXP: 5/20/2014.

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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