Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules In
Summary
The FDA issued a Class II for Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottle by Granules Pharmaceuticals Inc.. Reason: 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..
Details
Source
Drug Recall
External ID
D-0192-2025
Action Date
2025-01-15
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 4911311A, Exp. Date: 11/2025
Quantity Affected: 6,804 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-30
Company
Chantilly, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Granules Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Granules Pharmaceuticals Inc. have FDA actions?
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0192-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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