Consumers and health professionals are advised that Apotex, in consultation with the TGA, has initiated a recall of one batch of APO-Paracetamol 500 mg tablets due to the potential for contamination with pieces of latex.
These tablets (from batch number X40466, expiry date 05/2016) are sold in bulk to pharmacies and health facilities which then dispense them in dose administration aids, such as Webster-paks and dosette boxes.
Any tablet in this batch could contain small pieces of latex (likely to be from a latex glove) and potentially poses an allergy risk in a consumer with a latex allergy.
Apotex initiated the recall following one customer complaint regarding a piece of foreign material found to be embedded in an APO-Paracetamol 500 mg tablet. Apotex believes it was an isolated incident, but recalled the batch involved as a precaution.
The affected batch was first distributed to the market on 2 March 2015 and could have been supplied to consumers from that date.
There are no identifying markings on the tablets that would indicate which batch they are from. However, any dose administration aid containing APO-Paracetamol will include that product in its medicine listing.
Information for consumers
Consumers who use paracetamol supplied in a dose administration aid are advised to check the medicine listing on those aids.
If a dose administration aid contains APO-Paracetamol, return it to the supplying pharmacy for repacking with replacement paracetamol.
If you have any questions or concerns about this issue, speak to your health professional.
Information for health professionals
If you are treating a patient who is taking paracetamol supplied in a dose administration aid, advise them of this issue and instruct them to check the medicine listing on those aids.
If it contains APO-Paracetamol, advise them to return the dose administration aid to their pharmacy.
Be alert to the potential for allergic reactions to latex in susceptible patients.
Information for pharmacies and health facilities
Apotex has written to pharmacies and health facilities providing further information about this issue, including details of the recall process.
Pharmacies and health facilities should check any stocks of APO-Paracetamol 500 mg tablets and quarantine any from batch number X40466, expiry date 05/2016.
Pharmacies that have supplied dose administration aids that may have contained APO-Paracetamol from the affected batch should contact those patients or health facilities and arrange to repack those aids with replacement paracetamol.
If you have any questions or concerns about this issue, contact Apotex Customer Service on 1800 276 839.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.