On 22 July 2014, Wockhardt recalled three batches of Amoxicillin sodium powder, used in injections, after their use caused serious reactions around the injection site. The Medicines and Healthcare Products Regulatory Authority (“MHRA”) has issued a Class II Safety Notice.
Pryers are aware of five cases of injury occurring within a 24 hour period in a single hospital in the Bristol area as well as five further cases in Buckinghamshire. It is a very common drug and may well have occurred elsewhere. The drug, intended to treat bacterial infections, in a few cases has caused severe chemical burns leaving scarring in both children and adults.
Wockhardt initially reacted after receiving a number of reports of reactions in babies and young children and therefore issued a drug alert on 9 July 2014 stating that it should no longer be used for those particular patients. The company then took matters up with their sub-contractor, an Italian company who manufacturers the drug for them, before ultimately recalling three specific batches.
Pryers are now investigating a number of cases where this reaction has occurred in an otherwise safe drug. It appears that there has been an issue with the manufacturing process or the quality control.