RecallRadar

FDA Drug recall D-1388-2014

Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 3…

On 2014-06-25 the FDA classified a Class II recall of Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 3… by John W Hollis, citing lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1388-2014
ClassificationClass II
Statusterminated
Initiated2014-05-12
Published2014-06-25
Last updated2026-09-13 11:51 UTC
CompanyJohn W Hollis
DistributionUS

Product

Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1388-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.