Sun Pharmaceutical, which has been dealing with FDA concerns over plants in India, is now recalling more than 12,000 bottles of a beta blocker made at a plant in Hungary.
According to the most recent FDA Enforcement Report, Sun is recalling 12,109 bottles of Carvedilol tablets manufactured at its Alkaloida Chemical site in Tiszavasvari, Hungary.
The voluntary recall, which has just been classified by the FDA, began in June. The four recalls were initiated after the products failed impurities and degradation testing, the report says.
In June, Sun also began a recall of 16,085 bottles of the antidepressant bupropion hydrochloride extended-release tablets manufactured at its Halol, India, plant because they failed specifications for dissolution.
The plant is one of Sun's primary facilities for providing products to the U.S., so Sun saw sales slip after the FDA cited its Halol plant with a Form 483 in 2014. The agency issued a warning letter to the plant last December for a host of quality and data integrity issues, and the drugmaker recalled a number of products as a result.
More recently, Sun’s manufacturing shortcomings surfaced in the U.S., this time at a plant in Philadelphia which it sold in June to Frontida BioPharm. The FDA hit the plant with a warning letter last month. Frontida has said that Sun was upfront with it about the FDA’s concerns when it bought the plant and that Sun has agreed to work with Frontida to get the facility into shape.
Frontida, a newly formed CDMO, is an affiliate company to Frontage Laboratories, a long-standing CRO in Pennsylvania, New Jersey and China that is controlled by Chinese CRO Hangzhou Tigermed.
The warning letter for the Philly plant said its quality unit “knowingly released 27 lots of various strengths of clonidine HCl tablets in March 2015,” despite evidence that the active pharmaceutical ingredient to make them “was potentially contaminated.”
- access the recalls here
Sun Pharma nagged by Halol plant recall
Frontida says it had full knowledge of FDA issues of Sun's Mutual plant in Philly
Frontida gets warning letter for plant it just bought from Sun