Why it was recalled
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Product description
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Lot numbers, UPCs & expiration codes
Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
Where it was sold
Nationwide
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-0838-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 24, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- 4694 30x60-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0838-2020, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84754
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
- Postal code
- 08536-0009
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0838-2020
- Classification
- Class III
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 4694 30x60-count bottles
- Termination date
- Dec 16, 2022
- Reason for recall
- Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2020