FDA recall D-0192-2025

Product

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

Reason for recall

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Distribution

Distributor in OH.

Key facts

Status

Terminated

Initiation date

2024-12-30

Report date

2025-01-15

Termination date

2026-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0192-2025