Dive Brief:
- The wholly-owned U.S. subsidiary of Sun Pharmaceutical Industries has voluntarily recalled one lot of 2,508 bottles of extended release metformin hydrochloride tablets, following the finding of a piece of rubber glove in one tablet.
- The lot was manufactured in-house at Sun's Halol facility and the recall is ongoing. BioPharma Dive reached out to Sun for further information but received no response.
- This is a class II recall, meaning the issue is unlikely to cause serious health consequences and any adverse effects may be temporary or medically-reversible.
Dive Insight:
In order to keep costs down, many drug developers outsource manufacturing — particularly to countries with lower labor costs.
However, this moves things far away from the originator company's oversight. In order to ensure drugs produced outside the U.S. are safe, the Food and Drug Administration keeps tabs on foreign manufacturers. The agency has become increasingly strict in recent years, though, spurring voluntary recalls, warning letters and bans on drug imports into the U.S.
Sun Pharma, meanwhile, has been facing manufacturing issues with its metformin products. Back in November 2017, the U.S. subsidiary carried out a nationwide voluntary recall of two lots of Riomet (metformin oral solution). Produced by an undisclosed contract manufacturer, routine 12-month stability testing found these to be contaminated with the fungal pathogen Scopulariopsis brevicaulis.
Sun's streak of manufacturing issues with metformin hasn't ended either. In April, the company voluntarily recalled nearly 20,000 473 mL bottles of Riomet manufactured by Mikart because of labeling discrepancies in the patient literature. The recall is ongoing.
The latest recall of around 2,500 metformin hydrochloride bottles further mars Sun's track record. Over the past couple of years, its U.S. arm has also had to recall carbidopa and levodopa tablets for dissolution failures and olanzapine tablets for impurities.
Yet Sun isn't the only manufacturer at odds with regulators. In February, there was a recall for 7,476 500-count bottles of metformin HCl tablets manufactured for Aurobindo Pharma, after a metformin BP 1000 mg tablet was found in a bottle of metformin HCl 1000 mg tablets.