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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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