In the latest update in this year’s saga of eye drop issues, the FDA released a preliminary inspection report regarding a recent visit to the India-based manufacturer of the 27 eye drops the agency warned against using in October 2023.
Background first, please.
The FDA issued a warning on Oct. 27, 2023 for consumers to immediately stop the purchase and use of 27 over-the-counter (OTC) eye drop products due to a potential risk for infection.
Among the marketed brands were:
- CVS Health
- Leader (Cardinal Health)
- Rugby Cardinal Health
- Rite Aid
- Target Up & Up
- Velocity Pharma
- Walmart
And see here for the complete list of products.
Were these recalled?
Per the FDA, Target, CVS, and Rite Aid, and Walmart agreed to remove them from store shelves and online; however, “Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online which should not be purchased.
To note, on Nov. 3, 2023, Cardinal Health Inc. initiated a voluntary recall for all lots of six Leader branded products (the FDA previously only included five products, which has been updated).
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratory brand drops.
Further as of Nov. 15, 2023, no adverse reactions have been reported.
How did this come about?
The warning followed an inspection by the FDA of the facility in Mumbai, India-based Kilitch Healthcare India Limited, the manufacturer of the products, from Oct. 12, 2023 through Oct. 20, 2023.
The agency’s investigators uncovered unsanitary conditions in the facility as well as positive bacterial test results from an environmental sampling of critical drug production areas within the facility.
Did Kilitch Healthcare recall these products?
Not initially. However, on Nov. 13, 2023, the company finally issued a voluntary recall for the listed products, ranging in expiration dates from November 2023 to September 2025.
Gotcha. Now talk about these preliminary findings.
First thing to know: this inspection was reportedly the first by the FDA for Kilitch Healthcare.
A list of 14 observations were reported, including (but not limited to):
- Contamination procedures for sterility not followed
- Omitted or falsified contamination test results
- Inadequate validation of the aseptic process
- Unclean and unsanitary building conditions
- No documentation of test procedure performance
- Quality control units procedures not documented
- Incomplete testing for product identification verification
- Incomplete production and control records for product batches
Any other specifics?
The agency also noted “water stains, cracks, and paint peeling off the ceiling,” as well as barefoot employees.“There has been no evaluation to determine any appropriate specifications for impurities or degradation products for US market… products during release and stability testing,” the report stated.
Other observations included a microbiologist backdating false sterility testing entries for U.S. market-bound product batches. Per the report, the employee “confirmed times recorded into the backdated records were not accurate.”
See here for the complete preliminary report of observations.
So what’s next?
A formal report will likely be released in the coming months with additional information regarding the FDA inspectors’ observations as well as the potential for warning letters to be sent to Kilitch Healthcare.