April 25, 2024

Representative Picture | Photo: Bloomberg


Eugia, a unit of Hyderabad-based Aurobindo Pharma, has issued a voluntary recall of a batch of its Methocarbamol injections used to treat musculoskeletal conditions after a US customer complained about finding white particles floating inside a vial.


According to a letter issued by the company dated March 22, the recall affects lot number 3MC23011 with an expiration date of November 2025. This batch contains 1,000 milligram/10-milliliter single-dose vials and was distributed across the US in January.


“Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs, or brain which can cause stroke and even lead to death,” Eugia said in the letter.


The pharmaceutical company said it had not received any reports of patient problems related to the recall. Methocarbamol injection is used for the relief of discomfort associated with acute, painful musculoskeletal conditions.


Eugia recently came under the Food and Drug Administration’s (FDA’s) scrutiny following inspections at its facilities. It was issued a Form 483 by the United States Food and Drug Administration (USFDA) in March which highlighted seven manufacturing problems at its facility in Telangana. Its New Jersey facility too came under the lens of USFDA in December. However, in February Empower Pharmacy said that it planned to buy the Jersey facility for an undisclosed sum.


In March, Sun Pharma issued a recall of gout drug due to microbial contamination of more than 55,000 bottles of febuxostat tablets at the company’s manufacturing facility. In December, the Mumbai-based company recalled 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid. The lot was manufactured at the drugmaker’s Dadra-based facility.


Its peer Lupin too recalled an unspecified number of penicillamine tablets in the US around December due to failed dissolution specifications. The medication is used to treat rheumatoid arthritis and Wilson’s disease. Baltimore-based Lupin Pharmaceuticals Inc, a unit of the company, recalled the affected lot that was produced at the drugmaker’s Nagpur-based facility.


Types of Recalls under USFDA


>>>Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death


>>>Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences


>>>Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

First Published: Apr 03 2024 | 5:19 PM IST