Wockhardt’s Problems Continue With Recall of U.S. Products

Beleaguered Indian generics maker Wockhardt said it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns.

The sites have been under an FDA import alert banning distribution of their products in the U.S. since November 2013.

The recall was triggered by a March 9 to17 inspection of the Chikalthana plant, which
cited the company for poor in-processing sampling and failure to complete annual product reviews for drugs made in 2012 and 2013, a Form 483 says. In all, investigators found 11 deviations, including incomplete complaint investigations, failure to follow quality control procedures, ineffective employee training, failure to submit field alert reports on time and poor laboratory controls.

Wockhardt Chairman Habil Khorakiwala said the voluntary recall will help to resolve the FDA’s concerns about the plant and stressed that patients aren’t at risk.

The import ban stemmed from good manufacturing practice and data integrity issues observed during 2013 inspections. Data integrity issues at both plants have since been resolved, Khorakiwala said.

Wockhardt had two major recalls last year, both due to problems with how drugs dissolved. In April, the company recalled 109,744 bottles of its hypertension drug metoprolol because of dissolution issues and, in July, more than 11,600 bottles of its generic Toprol-XL.

Last April, India suspended sales of Wockhardt’s fixed-dose combination dicyclomine hydrochloride 10 mg, tramadol hydrochloride 50 mg and acetaminophen 325 mg following the FDA import alert and the July recall. Regulators in the UK also ordered the firm to stop making products for the European market.

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