Pfizer has confirmed that the Heparin-Lignocaine mixup occurred at one pharmacy, not its own facilities
But the recall for Heparin Injection 5000 IU 5mL x 50 and Lignocaine Injection 1% (50mL in 5mL) remains in place, it said in a statement.
Pfizer was advised on August 10 that a patient had been dispensed a box of Heparin Injection which contained Lignocaine and a recall was commenced.
“We have completed a comprehensive investigation of our manufacturing, packaging and distribution processes for both Lignocaine and Heparin and we are convinced this issue did not occur at a Pfizer manufacturing facility or at Pfizer’s distribution centre,” Pfizer says now.
“Pfizer is confident this is an isolated incident involving one pharmacy after the products left Pfizer’s distribution chain.
“Delivering medicines safely to patients is a shared responsibility and our priority now is to work closely with others in the supply chain to identify the root cause and take corrective action.
“In the interests of patient safety and in consultation with the Therapeutic Goods Administration, Pfizer is conducting a recall for product correction for the affected batches of medication.”
Pfizer and the TGA are requesting that patients inspect the products they have on hand and if they find any Lignocaine ampoules inside a Heparin box, or vice versa, to return it to the pharmacy where they purchased the product.
“Pfizer is undertaking this voluntary action as a precautionary measure,” it says.
“The probability of finding affected stock from impacted batches is considered low.
“Product that has not been found to show any anomalies may be used as normal, until the expiry date given on the box and on the ampoules.
“There is no greater priority to Pfizer than patient safety, and maintaining the integrity of our supply chain is paramount to this.”
The affected batches are:
HEPARIN SODIUM 5000IU/5mL (porcine mucous) injection ampoule 50 pack AUST R 49232
On the Cartons: (B) : A473, EXP: FEB 19
On the Ampoules: 473, EXP: FEB 19
Pfizer (Perth) LIGNOCAINE HYDROCHLORIDE 1% (50mg/5mL) injection BP ampoule AUST R 49296
On the Cartons: (B): A313, EXP: NOV 17
On the Ampoules: A313, EXP: NOV 17