UK-based William Ransom & Son has been advised to voluntarily recall certain products following a false contamination scare at its Witham, Essex, facility.
The country's oldest independent pharmaceutical company has also had its Manufacturer's License for certain products suspended for three months.
The products affected include Radian (menthol, camphor, methyl salicylate, aspirin), Valderma (potassium hydroxyquinoline sulphate, chlorocresol), and Pavacol (pholcodine) brands, and covers only these products in current shelf life.
The move comes after a routine inspection of the Witham pharmaceutical contract manufacturing facility by the Medicine and Healthcare Products Regulatory Agency (MHRA) in November.
The inspection "found some evidence of deficiencies in the company's control and investigation of microbial contamination of the purified water supply used in the manufacture of certain products", a statement released by the company said.
According to an undisclosed source, there was no contamination at the plant and the MHRA's investigation findings were a result of an erroneous reading and an "oversight on paperwork".
Specific details were unavailable.
"The company believes that its existing quality management system has ensured that all product sold is within its specification for release to the market. Moreover there have been no adverse events reported to the company in the last 12 months arising from microbial contamination," William Ransom & Son said in a statement.
"In its discussions with the MHRA, the company has accepted that there were shortcomings in its documentation of the review and decision making process concerning microbial contamination. These have since been rectified."
According to William Ransom & Son, the "shortcomings" did not compromise the safety of the public and this position had been supported by independent filings by experts to the MHRA.
"We have been making products for ourselves and our customers to the highest standards for many years with no reported incidences of quality issues. We are committed to working with the MHRA to resolve the current situation as quickly as possible," William Ransom & Son chief executive Tim Dye said in a statement.
The company was unable to comment on the number of packages affected in the recall or how much the recall and loss of license would cost the company.
The recall does not affect other consumer healthcare products manufactured or sold by the company.
Topical analgesic treatment Radian and antibacterial Valderma were acquired by William Ransom & Son in 2002 from Roche. Cough suppressant Pavacol was taken on in an additional acquisition.