Lupin Recalls 51k Bottles Of Generic Antibiotic Drug In US

New Delhi: Drug firm Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the U.S. market due to a “defective container”, according to the American health regulator.

The U.S.-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to “defective container: lack of seal integrity,” U.S. Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Cefrine Oral Suspension is indicated for the treatment of a range of bacterial infections.

The affected lot has been manufactured at Lupin’s Mandideep-based plant and marketed in the U.S. by Baltimore-based Lupin Pharmaceuticals, Inc., it said. The drug maker initiated the Class II nationwide (U.S.) voluntary recall on May 8 this year.

As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

India is the largest supplier of generic medicines with around 20% share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the U.S. as the main destinations.

Related Posts

  • Pharma
  • June 21, 2024
  • 52 views
Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of May, has revealed that the carbapenem antibiotic Meropenem is linked with adverse drug…

  • Pharma
  • June 21, 2024
  • 61 views
Plan To Regulate Nutraceutical Industry Underway

NEW DELHI: India’s foods regulator is working on a draft regulation to clearly demarcate nutraceuticals and pharmaceutical drugs, to eliminate ambiguity and ensure that health supplements that are borderline pharma…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem

Plan To Regulate Nutraceutical Industry Underway

Plan To Regulate Nutraceutical Industry Underway

Ayush And Herbal Products Exports Grow Over 20% In April

Ayush And Herbal Products Exports Grow Over 20% In April

NMC Says No Antibiotics Before Diagnostic Tests

NMC Says No Antibiotics Before Diagnostic Tests

Health, Drug Control Officials To Monitor Sale Of Abortion Kits

Health, Drug Control Officials To Monitor Sale Of Abortion Kits

Punjab: 11-Month-Old Given Expired Vaccine At Amritsar’s Private Hospital

Punjab: 11-Month-Old Given Expired Vaccine At Amritsar’s Private Hospital