Reported Jun 25, 2014 · Terminated

Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist,…

John W Hollis Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: John W Hollis Inc · 110 20th Ave N · Nashville, TN · 37203-2315

Lot codes and dates: 17 of 17 products
Products covered by this recall
# Product as published
1 Lot: 2319, best used by 6/04/14
2 Lot: 2510, best used by 6/22/14
3 Lot: 2576, best used by 6/25/14
4 Lot: 2624, best by 6/30/14
5 Lot: 2744, best used by 7/08/14
6 Lot: 3048, best used by 7/30/14
7 Lot: 3062, best used by 7/31/14
8 Lot: 3106, best used by 8/6/14
9 10 mL: Lot 2084, best used by 5/19/14
10 Lot 2318, best used by 6/04/14
11 Lot: 2369, best used by 6/10/04
12 Lot: 2396, best used by 6/11/14
13 Lot: 2576, best used by 6/25/14
14 Lot: 2744, best used by 7/08/14
15 Lot: 3062, best used by 7/31/14
16 Lot: 3106, best used by 8/6/14
17 Lot: 3123, best used by 8/10/14
Amount recalled: 365 mL

The agency filed one notice per product. You are reading one of them; the other 18 are below.

6 more are in the archive.

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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