The Recall Desk
ModerateFDA (Drugs)·D-896-2014·Announced 2014-01-29

Aidapak Recalls Mislabeled Triamterene/HCTZ Tablets Due to Label Mixup

Aidapak Services, LLC is recalling Triamterene/HCTZ tablets that may have been mislabeled as Caffeine tablets. The error involves a label mixup during repacking.

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

Plain-English summary

Aidapak Services, LLC is recalling Triamterene/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201. The recall is due to a labeling error where the product may have been mislabeled as Caffeine, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173. The specific pedigree for the affected Triamterene/HCTZ is AD28333_4 with an expiration date of 5/6/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating a situation where 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 Triamterene/HCTZ tablets with pedigree AD28333_4 and expiration date 5/6/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for credit.

The recalled product

Product
TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378135201.
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)

  • TRIAMTERENE/HCTZ
  • Tablet
  • 37.5 mg/25 mghas the following codes: Pedigree: AD28333_4
  • EXP: 5/6/2014.

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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