Polidocanol 5% Injection (John W Hollis) – sterility risk (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Brand
John W Hollis Inc
Lot Codes / Batch Numbers
Lot 1076, use by 08/28/14, Lot 2410, use by 09/13/14, Lot 2746, use by 10/06/14
Products Sold
Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14
John W Hollis Inc is recalling Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains due to Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026