FDAClass IIJune 25, 2014

Polidocanol 0.5% Solution for Injection recall: Sterility Concern

Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203…

Why was Polidocanol 0.5% Solution for Injection recalled?

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15

Product
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203…
Recalling firm
John W Hollis Inc
Quantity
300 mL
Distribution
Nationwide
Recall date
June 25, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls