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 assurance of sterility.
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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
John W Hollis Inc is recalling specific lots of compounded injectable products containing Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, and Alprostadil 40 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 5 mL vials with lot numbers 2543, 2137, 3056, and 3081, and 10 mL vials with lot numbers 2194 and 2950.
Consumers and healthcare providers should stop using the affected products 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 40 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 (12)
- a) 5 mL: Lot: 2543
- best used by 3/24/14
- Lot: 2137
- best used by 5/25/14
- Lot 3056
- best used by 7/30/14
- Lot: 3081
- best used by 8/04/14
- b) 10 mL: Lot: 2194
- best used by 5/26/14
- Lot: 2950
- best used by 7/22/14
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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