| TGA Action ID |
RC-2025-RN-00621-1 |
| Type of Product |
Medicine |
| Product Name/Description |
BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled syringe with needle
Lot Numbers: LT0106, HJ3234
Product code: F000156028
Expiry Dates: 30 Sep 2027, 30 Sep 2026 |
| ARTG Number |
147169 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Alert |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
Particulates have been identified during visual inspection of certain lots of BICILLIN L-A 1,200,000 Units/ 2.3 mL.
If impacted product is administered to a patient, there is a potential for a mild hypersensitive reaction, rash, oedema, infections, or blocked needle diameter resulting in inability to deliver a full dose.
There have been no product quality complaints or adverse events to date for the impacted batches related to this problem. |
| Instructions for Customers/Users |
Replacement stock is currently unavailable due to a current shortage of the medicine.
If customers have any affected stock, Pfizer suggests the following to mitigate the risk:
1. Perform careful visual inspection of any syringe prior to administration to confirm that it contains no particulate matter.
2. Discard the syringe should particulate matter be observed. Do not administer to patients.
3. If abnormal resistance is encountered from the syringe plunger during administration to a patient, discontinue usage. Discard the used syringe and assess if a replacement dose is required.
4. Follow usual procedures to monitor patients post-administration for reactions including, but not limited to, local foreign body reactions and infections, and report any and all suspected adverse events to the TGA via http://www.tga.gov.au/reporting-problems or to Pfizer on: 1800 675 229 or by email to: AUS.AEReporting@pfizer.com.
For any medical information customers can call 1800 675 229 – Pfizer Medical Information.
Update 9/09/25:
Pfizer is advising that Australia has received a limited amount of new stock and is being distributed to wholesalers.
Customers are to continue to follow the previous instructions while the stock levels are monitored and managed.
Customers can contact Pfizer Customer Service on 1800 629 921 with enquiries on stock availability.
This action has been closed out on 29/10/2025 |
| Action Commencement Date |
24/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 629 921 – Pfizer Customer Service |