Why it was recalled
Superpotent
Product description
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
Lot numbers, UPCs & expiration codes
Lot # BPF901A, exp. date 12/2021
Where it was sold
Product was shipped to 8 distributors who may have further distributed the product.
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-0140-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2019
- FDA report date
- Oct 23, 2019
- Quantity
- 31,968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0140-2020, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83960
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot # BPF901A, exp. date 12/2021
- Postal code
- 08536-0009
- Report date
- Oct 23, 2019
- Product type
- Drugs
- Recall number
- D-0140-2020
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 31,968 bottles
- Termination date
- Feb 23, 2021
- Reason for recall
- Superpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was shipped to 8 distributors who may have further distributed the product.
- Recall initiation date
- Sep 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2019