India’s Lupin is recalling products again, and again it is for having manufactured drugs with an ingredient that failed specifications.
After recently having to recall nearly 54,000 vials of an antibiotic made at its plant in Mandideep, India, the drugmaker is now recalling nearly 86,000 bottles of blood pressure meds manufactured at a plant in Pithampur, according to the latest FDA Enforcement Report.
The drugmaker is recalling 59,520 bottles of the combo drug lisinopril and hydrochlorothiazide. It also is recalling 26,467 bottles of lisinopril tablets. Classified this week by the FDA, the company actually began the recall in April.
This retrieval comes on the heels of Lupin’s recall of 53,902 vials of injected ceftriaxone. In that case, the drugs were manufactured at a plant that Lupin had disclosed in March had received a Form 483 following an FDA inspection.
Lupin last year also received a Form 483 with 9 observations for a plant in Goa, and the year before the FDA cited a facility in Indore with half a dozen.
The recalls come as Lupin is trying hard to increase its market share in the U.S. Earlier this year it laid out $900 million to buy New Jersey-based Gavis Pharmaceuticals, getting a 45,000-square-foot manufacturing and R&D site and a 124,000-square-foot packaging and distribution operation in Somerset, NJ, as part of the deal. It also got a portfolio of 120 marketed products and 62 ANDA filings.
- access the recalls here
Related Articles:
Lupin recalling antibiotic produced at plant cited by FDA
FDA cites Lupin Indian facilities for what drugmaker calls 'minor' issues
Lupin gets first U.S. manufacturing base with buyout of GAVIS