CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Papaverine 60 mg, Phentolamine 4 mg recalled by John W Hollis
John W Hollis is recalling Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution Vial, distributed in Missouri, Mississippi, Tennessee, Wisconsin. The recall was initiated on 17 Mar 2014 and the FDA has classified it as Class III.
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-1258-2014
- FDA event ID
- 67812
- Recalling firm
- John W Hollis, Nashville, TN
- Classification
- Class III
- 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
- Other Reasons
- 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
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Product as listed by the FDA
Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 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?
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Which lots are affected?
Lot #: 1905, Expiry: 4/30/14
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 67812| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Polidocanol 3% Solution Vial recalled by John W Hollis | John W Hollis | Particulate Matter | 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 Papaverine recalls
All 64| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled | Pharmacy Plus | Sterility | 4 states |