News

Article

MHRA Recalls Medicines Made at Wockhardt's Waluj Site

The precautionary recall follows manufacturing deficiencies identified at the site in India.

MHRA issued a precautionary recall of 16 different prescription medicines made by Wockhardt at its Waluj site in India because MHRA identified manufacturing deficiencies during an inspection and noted that the medicines have not been manufactured to GMP standards. The recall was issued to pharmacies, dispensing clinics, and wholesalers, but not patients, MHRA noted in the press release.

The deficiencies identified by the MHRA during a routine inspection in March included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten. The MHRA is working with Wockhardt and other international regulators to resolve these issues.

MHRA indicated that this is not a patient-level recall because, although the medicines that are affected have not been manufactured to GMP standards, there is no evidence of a patient-safety risk from medicines that have been sold in the UK. Poor manufacturing standards cannot be allowed to continue, however, noted the agency.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Related Content