In its third U.S. recall in less than a year, India's Macleods is pulling 10,052 bottles of the antibiotic levofloxacin because of labeling issues.
The FDA revealed the recall by Macleods Pharma, the U.S. unit of the Indian drugmaker, on its website Wednesday. The company initiated the recall, which covers products distributed throughout the U.S. and Puerto Rico, on January 5.
A “mismatching of the embossing on the tablets with the embossing specified in the package insert” prompted the product pull, according to the FDA. Macleods made the pills at its Baddi manufacturing facility in Himachal Pradesh, India.
It's not the company's only manufacturing snafu in the last year. Last February, Macleods Pharma issued a pair of recalls for products used to treat high blood pressure and schizophrenia due to deviations from standard manufacturing protocols.
On February 15, 2022, the drugmaker pulled 3,672 bottles of amlodipine and olmesartan medoxomil tablets, which are used to treat high blood pressure. The following day it initiated a recall for one lot of 10 mg, 30-count bottles of olanzapine, which is used to treat schizophrenia.
Both of those recalls cited manufacturing "deviations” as the cause of the action.
Macleods was among a number of companies that issued recalls in 2019 for the high blood pressure treatment losartan that contained impurities traced back to APIs manufactured by Hetero Labs Limited.