Product Alert for Bicillin L-A 1.2 Million Units

HPS Pharmacies wish to give notice that Pfizer, in consultation with the Therapeutic Goods Administration (TGA), has issued a product alert for Bicillin L-A as follows:

Bicillin L-A
Benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL
ARTG 147169

This product alert was initiated following the identification of particulate matter during visual inspection of syringes. Affected syringes were rejected during the manufacturing process, and there is currently no evidence to suggest any of the released syringes from the below lots contain particulate matter. However, as Pfizer cannot exclude the possibility of a similar defect, a product alert has been issued.

The batches affected by this notice are:

• LT0106 (Exp 30 September 2027)
• HJ3234 (Exp 30 September 2026)

If impacted product is administered to a patient, Pfizer advises that there is a potential for a mild hypersensitive reaction, rash, oedema, infection, or needle blockage impacting the inability to deliver a full dose. No product quality complaints or adverse events related to the impacted batches have been reported with regards to this problem.

While there is no replacement stock due the current shortage, Pfizer makes the following recommendations to mitigate risk:

• Perform careful visual inspection of any syringe prior to administration.
• Discard the syringe if particulate matter is observed. Do not administer to patients.
• If abnormal resistance is encountered from the syringe plunger during administration, discontinue usage. Discard the used syringe and assess if a replacement dose is required.
• Follow usual procedures to monitor patients post-administration for reactions including, but not limited to, local foreign body reactions and infections.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.

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