Monday, April 1, 2019

Mylanta Antacid Double Strength Oral Liquid 500 mL Recalled By Johnson & Johnson Pacific - Australian Recalls

Image for Mylanta Double Strength - 500mL from Amcal

Mylanta Antacid Double Strength Oral Liquid 500 mL

Product defect correction - potential for soft lumps in the liquid
1 April 2019
Consumers and health professionals are advised that Johnson & Johnson Pacific, in consultation with the TGA, has issued a product defect correction for Mylanta Antacid Double Strength Oral Liquid 500 mL.
Mylanta Antacid Double Strength Oral Liquid 500 mL is an over-the-counter medicine used for relief from indigestion, heartburn, upset stomach, flatulence and wind pain.
It has been identified that soft lumps may form in one batch of this product (batch number 1079278, expiry June 2020), particularly if the bottle is not vigorously shaken prior to use, as per the directions on the label.
Soft lumps in the liquid can be easily visually detected when poured and can usually be addressed by vigorously shaking the bottle.
However, Johnson & Johnson Pacific is offering refunds to any consumers who continue to have issues or who are dissatisfied.
Johnson & Johnson Pacific is also withdrawing any remaining units from this batch from wholesalers.

Information for consumers

If you have Mylanta Antacid Double Strength Oral Liquid 500 mL with batch number batch number 1079278 (expiry June 2020), please be aware of this issue.
You are advised to shake the bottle vigorously (for up to 15 to 20 seconds) as referred to on the label which states, 'Shake well before use' and then visually check the liquid before ingesting. If present, soft lumps can be easily seen when the liquid is poured.
Consumers are reminded that after opening, the product is to then be refrigerated and discarded after six months, regardless of the expiry date printed on the pack, which in this case will be June 2020.
If vigorously shaking the bottle does not resolve the issue, or if you are dissatisfied, contact Johnson & Johnson Pacific on 1800 029 979 and arrange a refund.

Information for health professionals

Please be aware of this issue and advise patients accordingly if they seek advice.
If you have any questions or concerns about this issue, contact Johnson & Johnson Pacific on 1800 029 979.

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.

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