CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Polidocanol 3% Solution Vial recalled by John W Hollis
John W Hollis is recalling Polidocanol 3% Solution Vial, distributed in Missouri, Mississippi, Tennessee, Wisconsin. The recall was initiated on 17 Mar 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1260-2014
- FDA event ID
- 67812
- Recalling firm
- John W Hollis, Nashville, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Mar 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +39 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Where it was distributed
MO, TN, MS, WI
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #: 641:07, Expiry: 8/11/14
Where was it sold?
MO, TN, MS, WI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 67812This product is part of a recall event; the main page for the event is Papaverine 60 mg, Phentolamine 4 mg recalled by John W Hollis.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Papaverine 60 mg, Phentolamine 4 mg recalled by John W Hollis | John W Hollis | Other | 4 states | |
| CLASS II | Phosphatidylcholine Solution for Injection, 50 mg/ mL Vial recalled | John W Hollis | Other | 4 states | |
| CLASS III | Polidocanol 1% Solution Vial recalled by John W Hollis | John W Hollis | Other | 4 states |
More recalls from John W Hollis
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyanocobalamin For Intramuscular OR Subcutaneous Use Only recalled | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | MIC PLUS B12, Adenosine, L-Carnitine, Contains recalled by John W Hollis | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) and b) recalled | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate for Injection recalled by John W Hollis | John W Hollis | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin For Intramuscular OR Subcutaneous Use Only recalled | John W Hollis | Sterility | Nationwide |
Other Polidocanol Vial recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Polidocanol 1% Solution Vial recalled by John W Hollis | John W Hollis | Other | 4 states |