Recalls: Trypan Blue 0.06% Ophthalmic Solution and Alcohol-Free Mouthwash

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Recalls: Trypan Blue 0.06% Ophthalmic Solution and Alcohol-Free Mouthwash

Custom RX Compounding Pharmacy (Richfield, MN) and Medline (Mundelein, IL) recalled products within the past week. The recalled products were Custom RX’s “Trypan Blue 0.06% Ophthalmic Solution” and Medline’s alcohol-free mouthwash and hygiene kits.

On Aug. 26, Custom RX Compounding Pharmacy and FDA notified ophthalmologists, other healthcare professionals, and consumers about a nationwide recall of Trypan Blue 0.06% Ophthalmic Solution, used in cataract surgery, because it may be contaminated with Pseudomonas aeruginosa bacteria that, if applied to the eyes, might lead to serious injury or blindness. Custom Rx Pharmacy requests that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, the District of Columbia, and Pennsylvania. The recall includes, but may not be limited to, the following lot numbers: 05042005:[email protected], 05252005:[email protected], 06282005:[email protected], 08012005:[email protected], and 08182005:[email protected]

On Aug. 29, Medline and FDA notified healthcare professionals about a nationwide recall of alcohol-free mouthwash, and of hygiene kits containing the mouthwash, because of possible contamination with Burkholderia cepacia. People who have health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. The product was distributed to hospitals, medical centers, and long-term care facilities nationwide. There is no known distribution through retail sales. The Centers for Disease Control and Prevention have confirmed hospital illnesses associated with the use of the affected mouthwash in Texas and Florida.


–Erik Greb