Recalls / Class III
Class IIID-0838-2020
Product
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
- Brand name
- Pioglitazone And Metformin Hydrochloride
- Generic name
- Pioglitazone And Metformin Hydrochloride
- Active ingredients
- Metformin Hydrochloride, Pioglitazone Hydrochloride
- Route
- Oral
- NDCs
- 33342-176, 33342-177
- FDA application
- ANDA204802
- Affected lot / code info
- Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
Why it was recalled
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 4694 30x60-count bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-01-24
- FDA classified
- 2020-02-11
- Posted by FDA
- 2020-02-12
- Terminated
- 2022-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0838-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.