Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Drug: Polidocanol
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
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