Class II · Moderate risk Terminated
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC…
Reason Superpotent and Failed Tablet/Capsule Specifications
PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.
What was recalled
PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093204856.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-835-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pioglitazone recalls
See all
Class III · Low risk Terminated
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma…
Reason Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk Terminated
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro…
Reason Superpotent
Class II · Moderate risk Terminated
Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed…
Reason Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Class II · Moderate risk Terminated
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and…
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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