FDA recall D-0140-2020

Macleods Pharma Usa Inc · Class II · drug

Product

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

Reason for recall

Superpotent

Distribution

Product was shipped to 8 distributors who may have further distributed the product.

Key facts

Status
Terminated
Initiation date
2019-09-23
Report date
2019-10-23
Termination date
2021-02-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0140-2020