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One Manufacturer Linked to 26 Product Recalls
(Thursday, November 9, 2023) In the last 2 weeks, the FDA has recalled 26 over-the-counter (OTC) eye drop products sold at major pharmacies such as CVS, Rite-Aid, Target, Walmart, and others, all apparently linked to one manufacturer. The eye drops are suspected to be contaminated and their use poses a risk of infection in the eyes that could result in partial vision loss or blindness. This is an example of how the drug supply chains are closely interconnected posing risk to the consumers. Drug products applied to the eyes pose a higher risk than other topical products as they can bypass the body’s natural defenses. Hence, eye drops are required to be sterile. It seems that one manufacturer supplies OTC eye drops to several major national pharmacy chains in the country under multiple brand names. Sometime in late Oct, FDA investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility controlled by this supplier and recommended that all lots of the eye drops manufactured at this facility be immediately recalled. Since the original recall, initiated on 25th October, the recall has been expanded three times to include additional brands of the product involving 26 products sold at multiple outlets of 7 major retailers. There is no public information about the identity of this manufacturer or the location of the manufacturing site, but obviously, it is a big supplier used by all major pharmacies. This event highlights the high risk posed by sole suppliers of common drug products. This is not an uncommon or unique event. And there is not much the FDA or the public can do under these conditions. This is the reality of the US drug supply chain where many low-margin, common consumer goods are sourced from individual suppliers by multiple large pharmacy chains. Hence, events like this could potentially simultaneously affect several outlets from where consumers purchase products, likely exposing large populations to risks and creating shortages. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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