Drug manufacturer Wockhardt has initiated another round of recall of its high blood pressure drug in the United States after it failed dissolution test. This is the company's third recall of the same drug in the past four months.
The recall of 11,661 HDPE (high density polyethylene plastic bottles) of metoprolol succinate by the US subsidiary of Wockhardt started last month.
The United States Food and Drug Administration (FDA) in a notification on its website on August 27, classified the recall as Class II recall and said that Wockhardt USA has started recall of 100-count bottle (National Drug Code 64679-737-02) and 500-count bottle (NDC 64679-737-03) of prescription only drug metoprolol succinate extended-release tablets, USP 200 mg.
Reason of the recall was specified as dissolution failures found during testing of control samples at the four hour time point. A dissolution test is conducted to check the time taken for the active ingredient in a drug to release into the body, and help predict how the drug performs inside the body.
The FDA website said the recalled lots were manufactured at a Wockhardt plant in Mumbai. Metoprolol is a generic form of AstraZeneca Plc's branded drug Toprol.
According to the FDA website, a Class II recall is a situation in which 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. The past two recalls of metoprolol succinate were also classified as Class II.
Recalls of medicines by drug manufacturers are not something new, but the Mumbai-based company had to initiate recall of the same drug thrice in the past four-to-five months.
In May Wockhardt has recalled 109,744 bottles of metoprolol after it failed an almost similar dissolution test. In June, the company again recalled 8712 bottles due to failure in dissolution test.
A company spokesman did not immediately respond to an email request on Saturday.
In another notification on FDA website earlier this month Wockhardt USA initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from the US market. Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder.
The developments came at a time when two of the company's plants at Waluj and Chikalthana are under an FDA import ban regarding violations of the manufacturing standards. Its Morton Grove Chicago facility was also issued a Form 483 earlier this year. The facility contributes 50% to the company's US sales.
According to a pharma analyst, "This kind of recalls are not uncommon but since the company is already neck-deep in trouble, it is important to understand why such issues are arising despite measures taken for improving the quality of drugs and other remedial measures at the plant level. If Morton Grove receives an alert, it would be a huge blow for the company."
Wockhardt has reported 94% decline in its net profit in the first quarter of the current fiscal at Rs 19.95 crore due to ongoing FDA bans on its facilities in India.
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