Dr Reddy's recalls heartburn pill stocks from US

58,656 bottles of lansoprazole recalled

Drug maker Dr Reddy’s Laboratories has voluntarily recalled 58,656 bottles of its Lansoprazole formulation from the American market due to microbial contamination, the US Food and Drug Administration (FDA) notified on Thursday.

The drug, used for treatment of heartburn, is a generic version of Novartis’ Prevacid. According to the US regulator, the Hyderabad-headquartered company recalled the product in January.

Confirming the recall, a Dr Reddy’s spokesperson said the financial implications were insignificant, being related to limited stocks.

However, the company is currently not supplying the product to the US market and is investigating the reasons for the recall, classified as a ‘Class II’ one, indicating a remote chance of severe adverse consequences or death due to a product flaw.

On Thursday, its shares closed at Rs 2,734.15 on the BSE exchange, up 1.6 per cent from Wednesday’s Rs 2,690.. During the day, the shares touched a low of Rs 2691.

 

While such recalls are usual in global pharmaceutical markets, the development assumes significance because this is the third such recall by an Indian company in January itself. Before Dr Reddy's Laboratories, the US FDA notified similar class II recalls by Ranbaxy Laboratories and Sun Pharmaceutical Industries.

While Ranbaxy had recalled 64,626 bottles of Lipitor generic from the US market of January 16 after a potential dosage mix up was detected, Sun Pharmaceutical recalled 2528 bottles of metformin HCl extended tablets from the US on January 28.

Domestic drug makers are also already ailing in the American market due to increasing issues with their manufacturing practices. While all Indian facilities of Ranbaxy, which were earlier supplying to the US market, are now banned by the US FDA, domestic facilities of other generic drug makers such as Wockhardt, Agila Specialities, RPG Life Sciences have also come under the regulatory scanner recently for serious deviations from the manufacturing norms.

In fact, on Wednesday, the US regulator also announced a ban on imports from Sun Pharmaceutical Industries' cephalosporin manufacturing facility located at Karkhadi, Gujarat.
 

Drugs recalled by Indian firms in January (source: US FDA )
Company	Drug	stocks	reason	Date of recall
Dr Reddy’s Laboratories	Lansoprazole Delayed Release Capsules, USP 15 mg	58,656 Bottles	Microbial contamination	3-Jan-14
Ranbaxy	Atorvastatin Calcium Tablets, 10 mg	64,626 bottles	A pharmacist discovered atorvastatin 20 mg tablet inside a sealed bottle of atorvastatin 10 mg.	16-Jan-14
Sun Pharma	Metformin HCl Extended-Release Tablets, USP, 500 mg	2528 bottles	customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER	28-Jan-14