Urgent recall on Lucas’ Pawpaw ointment after ‘contamination’

Several batches of cult ointment Lucas’ Pawpaw are urgently being recalled by Australia’s medicine regulator due to microbial contamination.

The Therapeutic Goods Administration (TGA) issued the nationwide alert on Wednesday, June 6,  for 11 batches of the topical ointment for the treatment of sunburns and rashes, most commonly used as a lip balm.

⚠️Recall – Lucas’ Papaw Ointment ⚠️

Lucas’ Papaw Remedies is recalling several batches of Lucas’ Papaw Ointment (AUST L 13397) due to microbial contamination. The affected products come in 15g, 75g and 200g sizes.
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— TGA Australia (@TGAgovau) July 7, 2022

The microorganisms have been identified as Aspergillus tubingensis, Sordaria humana, Penicillium paneum and Paenibacillus glucanolyticus.

“These moulds and bacteria pose minimal risk to the general population,” the TGA said.

However, TGA noted that “there is a remote risk that individuals who are immunocompromised could become ill if they are exposed to these organisms.”

“In-line sampling to monitor the microbial content of batches in production returned out of specification (OOS) results greater than limits set by the sponsor,” the TGA said.

“Quality hold was placed on the products at distribution level, and the samples were retested at another validated laboratory for microbiology testing to allow for further confirmation of OOS results.

“Both validated microbiology laboratories for the sponsor have returned OOS results across bulk batches 00822 and 00522.”

The affected products and batch numbers are the following:

• Lucas’ Papaw Ointment 15g, Batch Number: 00522D22, Expiry: April 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822E25, Expiry: May 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822E26, Expiry: May 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822E27, Expiry: May 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822F01, Expiry: June 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822F03, Expiry: June 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822F06, Expiry: June 2025
• Lucas’ Papaw Ointment 15g, Batch Number: 00822E31, Expiry: May 2025
• Lucas’ Papaw Ointment 75g, Batch Number: 00522E04, Expiry: May 2025
• Lucas’ Papaw Ointment 75g, Batch Number: 00522E05, Expiry: May 2025
• Lucas’ Papaw Ointment 200g, Batch Number: 00822E30, Expiry: May 2025

Those who are using the ointment are advised to check their batch number, which is located at the crimp on the top of the 15g tube, or at the bottom of 75g and 200g containers.

TGA has also encouraged those who have an ointment from the affected batch to “immediately stop using it” and return it to the place of purchase for a refund or contact Lucas’ Papaw Remedies Customer Service on 1800 861 852.

No other batches or other Lucas’ Papaw Remedies products are being recalled at this time.