FDA Drug recall D-1397-2014
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 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 1 mg, Alprostadil 20 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-1397-2014 |
| 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 1 mg, Alprostadil 20 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: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624,…a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; b) 10 mL: Lot 2084, best used by 5/19/14; Lot 2318, best used by 6/04/14; Lot: 2369, best used by 6/10/04; Lot: 2396, best used by 6/11/14; Lot: 2576, best used by 6/25/14; Lot: 2744, best used by 7/08/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; Lot: 3123, best used by 8/10/14 |
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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-1397-2014%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.