Pharmacy chain Boots UK has expanded a recall of some own-brand drugs after detecting a fault in a manufacturing line that applies tamper evident seals.
The recall – announced on the Medicines and Healthcare products Regulatory Agency (MHRA) website earlier today – covers various batches of Boots’ liquid paracetamol, ibuprofen formulations as well as various cough and cold remedies.
Boots said it had “identified a possible fault in the manufacturing process of the tamper seal that might result in small pieces of plastic being found in the liquid medicines” but stressed that the recall is a precautionary measure.
The move expands the recall Boots initiated in November – which saw it withdraw five products – to a total of 11 products.
All of recalled products were produced at a facility in Nottingham, UK by Boots’ in-house contract manufacturing organisation (CMO) BCM.
A spokeswoman for BCM told in-Pharmatechnologist.com that: “The recall is a precautionary measure. We have not received complaints about any of the products made on the manufacturing line thought to be the cause of the problem.”
She went on to explain that the recall was prompted by problems with product packaging rather than the drugs themselves.
“We detected that the tamper evident ring was being pushed up during manufacturing and this may have caused it to become loose and break, creating a small risk that pieces of plastic could fall into the medicine.”
She went on to say that: “Corrective alterations have been made to the manufacturing line” and added that “in addition we are due to begin trialling a camera-based visual detection system to prevent any similar problems occurring in the future.”
The BCM spokeswoman also confirmed the firm is working contingency manufacturers to ensure supply of the recalled products is maintained.