Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
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