Drugmakers Dr Reddy's, Wockhardt, Ohm hit by US recall

The US Food and Drug Administration (FDA) has recently notified that three Indian pharma companies – Dr Reddy's Laboratories, Wockhardt and Ohm Laboratories (a subsidiary of Ranbaxy, now owned by Sun Pharmaceutical) – have initiated nationwide voluntary recalls of a number of drugs in the US market.

According to a notification on the FDA website, Hyderabad-based Dr Reddy's Labs has initiated recall of anti-convulsant and mood-stabilising drug Divalproex Sodium extended-release tablets of strength 250 mg and 500 mg. The prescription-only drug, which is used in treatment of certain types of seizures (epilepsy), was manufactured at Bachupally in Hyderabad. Around 7,479 of 100-count bottles (one lot with expiry September 2015) and 2,544 of 500-count bottles (two lots with expiry of September 2015) of strength 250 mg were recalled. For 500 mg strength, one lot with expiry of October 2015 has been recalled. No data on quantity distributed under 500 mg has been provided in the notification.

The ongoing class II recall was initiated by the US subsidiary of Dr Reddy's on May 22 and the reason for it is given as “failed dissolution specifications; exceeded specification at the 9 hour time point”, the notification said.

In a class II recall, use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

In another notification, the FDA said that Dr Reddy’s has also initiated recall of prescription-only drug Amlodipine Besylate and Atorvastatin calcium tablets in various strengths, such as 5mg/40mg (one batch with no mention of expiry) packaged in 30-count bottle and 90-count bottle, 10mg/40mg (one batch with no mention of expiry) in 90-count bottle, 10mg/10mg (two lots with expiry on July 2015) in 30-count and 90-count bottles and 5mg/10mg (two lots with expiry on July 2015), packaged in 30-count and 90-count bottles. 

The drug is used to treat high blood pressure (hypertension) or chest pain (angina), and to lower the risk of stroke, heart attack, and other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.

The medicines were manufactured at Bachupally in Andhra Pradesh and the reason for the ongoing Class III recall, initiated on May 6, was given as sub-potent drug.

In case of Class III recall, use of or exposure to a violative product is not likely to cause adverse health consequences.

Calvin Printer, vice president & head of corporate communications, Dr Reddy's Laboratories, said, “We confirm that we have initiated a voluntary recall of Divalporex. This has been done as an abundant precautionary measure by the company, based on observations related to the products dissolution specifications. The observations are being investigated at our end and we are confident of a satisfactory resolution at the earliest. Pending submission of the investigation report to the US FDA, we would not like to comment further at this stage.”

In another update on FDA website, Allegiant Health has initiated recall of 86,106 cartons of over-the-counter (OTC) heartburn drug famotidine tablets of 20 mg strength manufactured in India by Mumbai-based pharma company Wockhardt. The products were distributed by Fred’s Inc, Harmon Stores Inc, A&Z Pharmaceutical Inc and Demoulas Supermarkets Inc.

The ongoing nationwide Class II recall was initiated on May 12 and the reason is given as current good manufacturing practices (cGMP) deviation, as “failure of the manufacturer, Wockhardt, to adequately investigate customer complaints”.

The pharma company had said in April this year that it is voluntarily recalling around 12-15 drugs from the US market manufactured in its facilities at Aurangabad before the plants were hit by an import alert by the FDA.

Recently Wockhardt chairman Habil Khorakiwala said the decision of this voluntary recall would have an impact of $1-1.5 million on the company for April. Whether this recall by Allegiant Health is part of the same recall is not clear.

A Wockhardt spokesperson did not offer comment to an emailed query.

Ohm Laboratories Inc, the US subsidiary of Gurgaon-based Ranbaxy which is now a part of pharma major Sun Pharmaceutical Industries, has initiated nationwide recall of 2,592 blister packs with expiry of June 2016 of antihistamine Loratadine orally disintegrating tablets of 10 mg strength. The allergy relief medicine (used for allergy symptoms such as sneezing, watery eyes, runny nose) was distributed by CVS Pharmacy, Inc and Walgreen Co.

The ongoing Class III recall was initiated on May 4 and the reason for the recall is given as “superpotent drug, out of specification (OOS), result of assay.” A Sun Pharma spokesperson said that the company has no comments to offer.

An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology, continuous delivery, and molecular biology for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity (the analyte). The analyte can be a drug or biochemical substance or a cell in an organism or organic sample.