FDA Drug recall D-1391-2014
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alc…
- FDA Drug
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alc… 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
| Agency | FDA Drug |
|---|---|
| Recall number | D-1391-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-12 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | John W Hollis |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Identifiers
| code_info | Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14 |
|---|
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-1391-2014%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.