Recalls / Class II
Class IID-0450-2022
Product
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
- Brand name
- Pioglitazone
- Generic name
- Pioglitazone
- Active ingredient
- Pioglitazone Hydrochloride
- Route
- Oral
- NDCs
- 57237-219, 57237-220, 57237-221
- FDA application
- ANDA200268
- Affected lot / code info
- Batch # PF4520028B & PF4520028A, Exp. Date 11/2022
Why it was recalled
Superpotent and Failed Tablet/Capsule Specifications
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 792 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-12-29
- FDA classified
- 2022-01-24
- Posted by FDA
- 2022-02-02
- Terminated
- 2023-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0450-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.