Reported Feb 12, 2020 · Terminated
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods…
Macleods Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009
Is this the product you have?
- 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 byMacleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
- Lot codes and dates
Lot# BPA5903AEXP 05/2021BPA5819AEXP 11/2020
- Amount recalled
- 4694 30x60-count bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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