JOHANNESBURG, June 5 (Reuters) -
An investigation into two recalled batches of children's
cough syrup made in South Africa by Johnson & Johnson ( JNJ )
found no trace of a toxin, and no adverse events have been
reported from consuming the syrup, the country's drug regulator
said on Wednesday.
The South African Health Products Regulatory Authority
issued the recall in April, days after Nigeria's regulator
recalled the medicine - a batch of Benylin Paediatric Syrup made
in South Africa - over an unacceptably high level of a
potentially deadly toxic substance, diethylene glycol.
No adverse events have so far been reported in South
Africa or other African countries relating to the syrup, though
Kenya, Rwanda, Tanzania and Zimbabwe also issued recalls.
"SAHPRA also wishes to indicate that there is no record of
any adverse drug reactions relating to diethylene glycol for the
two recalled batches in South Africa or anywhere else where they
were exported to on the continent," the regulator said in a
statement.
Kenvue ( KVUE ), which owns the Benylin brand after a
spinoff from J&J last year, said its own tests of the recalled
batches found no trace of either diethylene glycol or another
closely linked toxin, ethylene glycol.
"We welcome the statement by SAHPRA reaffirming the
safety of the batches of Benylin Paediatric Syrup that were
subject to the recall," it said in a statement.
The contaminant diethylene glycol, and ethylene glycol, have
been linked to the deaths of more than 300 children in Cameroon,
Gambia, Indonesia and Uzbekistan since 2022. There is no
evidence that those incidents were linked with the recalls in
April.