The Department of Health (DH) today (June 11) endorsed a licensed drug wholesaler, Bausch & Lomb (HK) Ltd. (Bausch & Lomb), to conduct a voluntary recall of two batches (batch numbers: 151221 and 166592) of Muro 128 Eye Ointment 5% [registration number: HK-58397, 3.5g per box] from the market due to a quality issue.
The DH today received notification from Bausch & Lomb that the product's manufacturer in USA, Bausch & Lomb Incorporated, had found some crystal precipitates in Muro 128 Eye Ointment.
The manufacturer's investigation confirmed no anomalies or discrepancies during the manufacturing process and all chemical in process and release testing for all product lots were within specifications. The crystal precipitates may be due to the exposure of product to lower than expected temperature during transit or storage. Bausch & Lomb Incorporated initiated a voluntary recall of 22 affected batches of the product in co-ordination with the USFDA to the retail level. The potential risk of using the affected product includes ocular or corneal damage. The DH has requested Bausch & Lomb Incorporated to provide a detailed investigation report as soon as possible.
Muro 128 Eye Ointment 5%, containing sodium chloride, is an over-the-counter medicine used in the eye for temporary relief of swelling symptoms caused by fluid accumulation in the corneal stroma.
According to Bausch & Lomb, only two of the affected batches (batch numbers: 151221 and 166592), with 1152 boxes in total, had ever been imported to Hong Kong since May 2012. They were all supplied to local private doctors, a private hospital and pharmacies. No exportation of the product was conducted.
So far, the DH has not received any adverse reaction report related to the use of the product. The DH's investigation is continuing.
Bausch & Lomb has set up a hotline (2213-3820, 2213-3229) to answer related enquiries. The DH will closely monitor the recall.
"Health-care providers should stop supplying the affected product to their clients. Members of the public who are consuming the product should consult their health-care professionals if in doubt," a DH spokesman said.
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