Macleods Pharma recalls 10000 bottles of anti bacterial medication in US over labelling error

Published On 2023-01-27 06:00 GMT | Update On 2023-01-27 07:35 GMT

New Delhi: Macleods Pharmaceuticals is recalling around 10,000 bottles of generic antibiotic medication in the US market due to a labelling error, according to the US health regulator. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Macleods Pharma Inc, a US-based unit of the company, is recalling 10,052 bottles of Levofloxacin tablets, which are used to treat different types of bacterial infections.

The company is recalling the affected lot due to "mismatching of the embossing on the tablets with the embossing mentioned in the package insert in the distributed bottles."

Macleods manufactured the affected lot in its Baddi-based manufacturing plant in Himachal Pradesh. The company initiated the Class III recall in the US and Puerto Rico on January 5.

As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."

The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is by far the largest market for pharmaceutical products in the world.

In the last financial year, India's pharma exports stood at around USD 24.62 billion with the US, the UK, South Africa, Russia, and Nigeria emerging as the top five destinations.

Read also: Cipla, Macleods HIV child treatments approved in South Africa

Established in 1989, Macleods Pharmaceuticals is engaged in developing, manufacturing, and marketing a wide range of formulations across several major therapeutic areas including anti-infectives, cardiovascular, anti-diabetic, dermatology, and hormone treatment.

Article Source : with inputs

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Macleods Pharma recalls 10000 bottles of anti bacterial medication in US over labelling error

Similar News

Lupin Manufacturing Solutions: Empagliflozin API gets CADIFA approval from ANVISA, Brazil

Zydus Foundation Vice Chairperson Meha Patel appointed as Member of CII National Committee on Art & Culture for 2025-26

Eris Lifesciences Secures CDSCO Panel Nod to Conduct BE Study on Dapagliflozin, Pioglitazone, Metformin FDC

Delhi to form special committee to crush fake medicine racket

Roche Pharma teams up with 10 Govt Hospitals to power up clinical trial capacities in India

AstraZeneca's Proposal to Increase Sample Size in Zibotentan-Dapagliflozin Global Trial Gets SEC Nod

Govt Allows Stickering, Orders New MRPs Post GST Reduction, AiMeD Welcomes Directive

Sun Pharma Secures Interim Court Relief In URSOCOL Trademark Dispute