The Recall Desk
SevereFDA (Drugs)·D-786-2014·Announced 2014-01-29

FDA Recalls Repacked Progesterone Capsules Due to Potential Labeling Error

Aidapak Services is recalling repacked progesterone capsules that may be mislabeled as levothyroxine sodium tablets. The error could lead to patients receiving the wrong medication.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the potential for administering the wrong drug (progesterone vs. levothyroxine) is a significant health risk that aligns with the Severe classification for Class II drug recalls involving mislabeling of distinct therapeutic agents.

Plain-English summary

Aidapak Services, LLC is recalling 500-capsule bottles of repacked progesterone, 100 mg, capsules (NDC 00032170801). The recall is due to a labeling error where the product may be mislabeled as levothyroxine sodium, 12.5 mcg, tablets (NDC 00527134101). The affected pedigree is AD46320_1 with an expiration date of 5/15/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk of patients receiving an incorrect medication, which could result in therapeutic failure or adverse effects depending on the intended treatment.

Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received progesterone capsules that appear to be labeled as levothyroxine sodium. Do not take the medication if there is any doubt about its identity.

The recalled product

Product
PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032170801.
Affected units
500

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)

  • PROGESTERONE
  • Capsule
  • 100 mg has the following codes: Pedigree: AD46320_1
  • EXP: 5/15/2014.

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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