Why it was recalled
Superpotent and Failed Tablet/Capsule Specifications
Product description
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Lot numbers, UPCs & expiration codes
Batch # PF4520028B & PF4520028A, Exp. Date 11/2022
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0450-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 29, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 792 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0450-2022, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89323
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch # PF4520028B & PF4520028A, Exp. Date 11/2022
- Postal code
- 08520-1401
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0450-2022
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 792 bottles
- Termination date
- Dec 4, 2023
- Reason for recall
- Superpotent and Failed Tablet/Capsule Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2022