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A customer complaint revealed microbial contamination issues affecting lots with expiration dates in late 2018 and early 2019.
FDA has posted news that Rugby Laboratories and Major Pharmaceuticals, through efforts with their distributor, United Exchange Corp. (Cerritos, Calif), are recalling lots of purified water-based products: Rugby eye irrigating solution and Major eye wash, due to microbial contamination issues.
These problems, which could result in potentially sight-threatening eye infections for anyone using affected product, were brought to the attention of the manufacturers by a customer complaint. Both products were distributed throughout the US to wholesale and retail facilities, including hospitals and pharmacies. The companies are notifying distributors and customers of the recall by letter, and arranging for return of all recalled products.
The recall affects Major EyeWash lot numbers G15905-G15912 and G16901-G16907, as well as G16910 and G16911, with expiration dates in October and November 2018, and January through March 2019. Also affected are Rugby EyeWash lots G15908, 15909, 16904, 16908, 16912 and 16913, with expiration dates in October and November 2018 and January through March 2019.