Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Pioglitazone Hydrochloride Tablets USP 15 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Superpotent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07
Affected NDC
33342-0054-07
Compare with the code on your package — it is the most precise check available.
Drug: Pioglitazone Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pioglitazone NDC 33342-0054 |
HYDROCHLORIDE 15 mg/1 | Tablet Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-054-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0140-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pioglitazone recalls
See all
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Actoplus met XR
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
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Pioglitazone and Glimepiride Tablets
Failed Dissolution Specifications
Other recalls by Macleods Pharma Usa Inc
All 2019 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
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