Pioglitazone Tablets Recalled for Superpotent and Failed Specifications
Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.
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: This is an FDA Class II recall involving a prescription drug with manufacturing defects (superpotency and failed specifications) that could affect drug efficacy and patient safety. Class II recalls with potential health consequences warrant a Severe classification.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Pioglitazone Tablets USP, 45 mg (500 count bottles) distributed nationwide in the United States. The recall affects NDC 57237-221-05 with batch numbers PF4520028B and PF4520028A, expiring 11/2022. A total of 792 bottles are affected by this recall.
The tablets are being recalled because they are superpotent and fail to meet tablet specifications. This means some tablets contain higher amounts of the active ingredient than intended, and some tablets do not meet required manufacturing standards.
Patients taking this medication should consult their healthcare provider or pharmacist before taking further doses. Those who have dispensed this product should notify their customers and quarantine all affected stock. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- PIOGLITAZONE (PIOGLITAZONE)
- Brand
- PIOGLITAZONE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Hazard
- superpotency
- failed-specifications
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 (2)
- Batch # PF4520028B & PF4520028A
- Exp. Date 11/2022
UPCs (3)
- 0357237221303
- 0357237220306
- 0357237219300
Distribution
Distributed nationwide across the United States.
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