Heparin 5000 IU/5 mL injection 50 pack ampoules (Pfizer)

Recall for product correction - potential for incorrect product in package

11 August 2017

Consumers and health professionals are advised that Pfizer, in consultation with the TGA, is undertaking a recall for product correction of one batch (Batch A473, expiry date Feb 2019) of Heparin 5000 IU/5 mL injection 50 pack ampoules because of the potential for the packaging to contain another product. Users with potentially affected products are asked to inspect their packs to ensure they contain the correct medicine.

The recall for product correction was initiated after one NSW consumer being treated with Heparin 5000 IU/5 mL injection 50 pack ampoules, found the pack contained ampoules of a different Pfizer product, Lignocaine 50 mg/5 mL (Batch A313, expiry date Nov 2017). The consumer obtained the pack at a community pharmacy in NSW. Consumers and health professionals who identify a defective pack should follow the advice below.

Heparin is used as a "blood-thinner" in people susceptible to blood-clotting and Lignocaine is an anaesthetic.

If a patient has an affected pack, there is a risk that they will not have adequate supply of their medicine and could take the incorrect medicine, which could have serious health consequences.

The Lignocaine ampoules found inside Heparin packaging.
The Lignocaine ampoules found inside Heparin packaging.

Information for consumers

If you or someone you provide care for uses Heparin 5000 IU/5 mL injection 50 pack (Batch A473, expiry date Feb 2019), please carry out a visual inspection of the contents.

In the event any anomalies are found, return the product to your pharmacy for refund or replacement.

Product that has not been found to show any anomalies may be used as normal.

Please note that all ampoules supplied in a pack should be identical in all respects and any product details should match those on the external packaging. If you notice any discrepancies with your medicine, return the product to your pharmacist.

If you have any other questions or concerns about this issue, talk to your health professional.

Information for health professionals

If you treat patients who take Heparin 5000 IU/5 mL injection 50 pack ampoules or Lignocaine 50 mg/5 mL ampoules, please be aware of this issue.

Pfizer will be writing to pharmacists and distributors providing further information about this issue, including details of the recall process. Please inspect your stock and quarantine any defective Lignocaine 50 mg/5 mL ampoules (Batch A313, expiry date Nov 2017) and Heparin 5000 IU/5 mL injection 50 pack ampoules (Batch A473, expiry date Feb 2019) before returning them to your wholesaler.

Product that has not been found to show any anomalies may be used as normal.

Patients returning unused or partially used packs of Lignocaine 50 mg/5 mL ampoules or Heparin 5000 IU/5 mL injection 50 pack ampoules should be provided a full refund and, if possible, offered an equivalent product to ensure continuation of therapy and avoid any risks of discontinuation symptoms. An alternative can only be offered on presentation of a valid prescription, or emergency arrangements if allowed under your jurisdictional legislation. All stock returned to you by the patient must be returned to the wholesaler.

If you have any further questions or concerns about this issue, please contact Pfizer on 1800 675 229.

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.