John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of assurance of sterility.
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, which corresponds to a Severe severity score under the rubric for potential serious temporary or medically reversible health consequences.
Plain-English summary
John W Hollis Inc is recalling specific lots of compounded injectable products containing Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, and Alprostadil 10 mcg. The recall involves 5 mL and 10 mL vials distributed nationwide.
The recall was initiated due to a lack of assurance of sterility in the aseptically filled injectable products. The affected lots include Lot 2488 (best used by 6/19/14) for the 5 mL vials, and Lot 2264 (best used by 06/03/14) and Lot 2295 (best used by 06/04/14) for the 10 mL vials.
Consumers and healthcare providers should stop using these specific products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 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
- Hazard
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 (6)
- a) 5 mL: Lot: 2488
- best used by 6/19/14
- b) 10 mL: Lot: 2264
- best used by 06/03/14
- Lot: 2295
- best used by 06/04/14
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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