FDA Drug recall D-1399-2014
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N,…
- FDA Drug
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N,… 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-1399-2014 |
| 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
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 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_info | a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, b…a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14 |
|---|
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-1399-2014%22
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