Post-recall, OTC eye drop maker handed a warning letter from the FDA
In March, Pharmedica USA, LLC pulled some of its eye drops off of the shelves over the possibility of the product not being sterile, and its use could result in eye infections that cause blindness. Now the FDA has released a warning letter it sent to Pharmedica at the end of last month.
The letter said that the FDA investigator had noted that products that were supposed to be sterile were being prepared or held in unsanitary conditions, and may have become “contaminated with filth or rendered injurious to health.” The inspector also noted that the facility was “in a state of disrepair” and had no areas meant for sterile products.
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