FDA-Drug2020-02-12Class III
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
Macleods Pharma Usa Inc
Hazard
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Sold states
Nationwide
Affected count
4694 30x60-count bottles
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2020Don't want to check this manually?
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