John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection.
Plain-English summary
John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine HCl, phentolamine mesylate, and alprostadil. The recall is being conducted because of a lack of assurance of sterility in these aseptically filled products.
The affected products are available in 5 mL and 10 mL volumes. Specific lot numbers and expiration dates are listed in the structured product information. The recall covers a nationwide distribution pattern.
Consumers and healthcare providers should stop using the affected lots and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- 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
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Compounded Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- Lot: 2369
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by John W Hollis Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · John W Hollis Inc
See all →- SevereJohn W Hollis Inc Recalls Liver Derivative Complex Injection for Sterility Concerns
FDA (Drugs) · 2014-06-25
- SevereJohn W Hollis Inc Recalls Methylcobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-06-25
- SevereJohn W Hollis Inc Recalls Cyanocobalamin Injection Due to Sterility Concerns
FDA (Drugs) · 2014-06-25
- SevereJohn W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
FDA (Drugs) · 2014-06-25
- SevereJohn W Hollis Recalls Polidocanol Injection Due to Sterility Concerns
FDA (Drugs) · 2014-06-25
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- LowJohn W Hollis Recalls Papaverine, Phentolamine, and Atropine Solution Vials
FDA (Drugs) · 2014-05-07
- SevereFDA Recalls Injectable Solution Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
- SevereWells Pharmacy Recalls Injectable Compounded Drug Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereMoses Lake Pharmacy Recalls Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
- SevereFDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09