John W Hollis Inc Recalls Compounded Injectable Drug Due to Sterility Concerns
John W Hollis Inc is recalling a compounded injectable drug product due to a lack of assurance of sterility. The product is distributed nationwide.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
John W Hollis Inc is recalling a compounded pharmaceutical product containing Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, and Alprostadil 20 mcg in a 10 mL volume. The recall is being conducted because of a lack of assurance of sterility in the aseptically filled injectable products.
The affected product is identified by Lot 2187 with a best used by date of 05/26/14. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 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 (2)
- Lot: 2187
- best used by 05/26/14
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
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