CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
Dronedarone HCL, Tablet, 400 mg recalled by Aidapak Services
Aidapak Services is recalling Dronedarone HCL, Tablet, 400 mg, distributed in Arizona, California, Oregon, Washington. The recall was initiated on 2 Jul 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-782-2014
- FDA event ID
- 65690
- Recalling firm
- Aidapak Services, Vancouver, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2013
- FDA classified
- 20 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
Timeline
| 2 Jul 2013 | Recall initiated by company | |
| 20 Jan 2014 | Classified by FDA | +202 days |
| 29 Jan 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
DRONEDARONE HCL, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00024414260.
Where it was distributed
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Questions about this recall
Is Dronedarone HCL, Tablet, 400 mg recalled?
Yes. Aidapak Services recalled Dronedarone HCL, Tablet, 400 mg on 2 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-782-2014.
Why was it recalled?
Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: AD52778_40, EXP: 5/20/2014.
Which lots are affected?
DRONEDARONE HCL, Tablet, 400 mg has the following codes: Pedigree: AD52778_52, EXP: 5/20/2014.
Where was it sold?
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aidapak Services
All 538| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MERCapsuleTOPURINE, Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Selenium, Tablet, 50 mcg, Over The Counter recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Venlafaxine HCL, Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Ascorbic Acid, Tablet, 500 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Calcitriol, Capsule, 25 mcg recalled by Aidapak Services | Aidapak Services | Packaging Defects | 4 states |