The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues.
According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
The withdrawal was necessitated by undersized and oversized tablets, which could result in patients not receiving the expected dose, said the regulator. Caraco has initiated the recall. The FDA said the recall was valid nationwide and 22,156 bottles of the drug were in circulation in the US.
In November 2007, the FDA had asked Ranbaxy Laboratories to withdraw its Gabapentine tablets 600 mg from the US market for excessive impurity specification.
The FDA had also suspended production at the manufacturing facilities of Leineur Health Systems, Dr Reddy's Laboratories US partner for over the counter drugs, citing quality issues. Subsequently, Dr Reddy's severed the tie-up with Leineur Health and launched its own products in the US market.
Metformin Hydrochloride, a bio-equivalent of Bristol Myers Squibb's Glucophage, was launched by Caraco in the US in February 2002.
The loss of revenues by the withdrawal was not 'much significant' and could not be ascertained at this moment, said a company source. A US stock exchange listed company, Caraco had sales of $117 million in FY07 and markets over 40 products in the US market.
A Sun Pharma spokesperson declined to comment on the development.
- Citing efficacy and quality issues, the USFDA asked Caraco Pharmaceutical Laboratories to withdraw Metformin Hydrochloride from the US market
- The withdrawal was necessitated by undersized and oversized tablets, which could result in patients not receiving the expected dose
- In November 2007, the FDA asked Ranbaxy to withdraw its Gabapentine tablets for excessive impurity specification
- Caraco, a US stock exchange listed company, markets 40 products in the US market