Indian drugmaker Lupin hasn't had the easiest 2020, weathering an FDA warning letter, a drug recall and a COVID-19-related plant closure in rapid succession. Now, the Mumbai, India-based drugmaker is pulling thousands of bottles of a popular blood pressure med from U.S. shelves, and it's not alone, joined by Sun Pharma with its own U.S. drug recall over cross-contamination fears.
Lupin's U.S. arm will pull one lot of 10 mg lisinopril tablets in the United States, citing 20 mg tablets found in at least one bottle. The voluntary recall affects more than 11,000 bottles, the FDA's latest enforcement report said.
The suspect lot was produced at Lupin's plant in Nagpur, Maharashtra, India, but the recall exclusively affects U.S. markets, Business Standard reported, quoting a Lupin spokesperson. Shipments were originally sent to Ohio, but may have wound up in other regions across the U.S., the FDA said. Lisinopril is approved to treat high blood pressure and heart failure and can help curb risk of death in patients who've suffered a heart attack.
Meanwhile, fellow Mumbai-based drugmaker Sun Pharmaceutical initiated its own U.S. recall, in this case for one lot of 3,516 bottles of orally-dissolving clonazepam tablets, used to treat seizures, panic disorders and anxiety. The FDA enforcement report cited the recalled lot, shipped across the U.S., for potential cross-contamination with the antipsychotic drug clozapine.
It's been a bumpy ride for both drugmakers this year, but Lupin has certainly taken the lion's share of beatings from the FDA and the ongoing COVID-19 pandemic. The company kicked off the year with an FDA Form 483 slamming its site in Andhra Pradesh for a variety of quality control shortfalls.
In late May, the FDA included Lupin on a list of five drugmakers encouraged to pull extended release versions of metformin, a popular diabetes med, after detecting N-Nitrosodimethylamine (NDMA)—a likely human carcinogen—in some samples. The agency previously pushed recalls of the heartburn med Zantac and "sartan" blood pressure drugs for contamination with the same carcinogen.
After Lupin confirmed the FDA's tests, the drugmaker pulled 500- and 1,000-milligram versions of extended-release metformin in June. The recall covered 60-, 90- and 100-count bottles shipped nationwide between early November and late May.
Then, midway through July, Lupin announced a plant closure in India's western Gujarat state after 18 staffers tested positive for COVID-19, Indian officials reported.
Sun has had its own COVID-19 problems, too. Its operations in Baddi, Himachal Pradesh, India, were part of a massive manufacturing hub shutdown this summer triggered by a pandemic lockdown.