FDA recall D-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

Reason for recall

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-01-24

Report date

2020-02-12

Termination date

2022-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2020