Polidocanol 5% Solution for Injection — Class II drug recall D-1391-2014
Terminated recall by John W Hollis Inc, reported 2014-06-25, distributed nationwide. Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable produc
| Recall number | D-1391-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | John W Hollis Inc, Nashville, TN, United States |
| Recall initiated | 2014-05-12 |
| Classified | 2014-06-18 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2014-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 550 ml |
| Reason classes | sterility |
| Lot numbers | 1076, 2410, 2746 |
| Expiration dates | 2014-08-28, 2014-09-13, 2014-10-06 |
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 for recall
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1391-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.