John W Hollis Inc Recalls Compounded Injectable Drugs Due to Sterility Concerns
John W Hollis Inc is recalling compounded Papaverine HCl and Phentolamine Mesylate injectable products 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 and involves a lack of sterility assurance in injectable products, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
John W Hollis Inc is recalling specific lots of compounded Papaverine HCl 30 mg and Phentolamine Mesylate 1 mg injectable products. The recall is being conducted because of a lack of assurance of sterility in these aseptically filled injectable products.
The affected products are available in 5 mL and 10 mL vials. The recall covers specific lots with best used by dates ranging from May 26, 2014, to July 28, 2014. The total quantity involved is 170 mL. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected products and contact John W Hollis Inc at 615-327-3234 for further instructions.
The recalled product
- Product
- Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, 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 (11)
- a) 5 mL: Lot: 2297
- best used by 6/04/14
- Lot: 2578
- best used by 6/25/14
- Lot: 2672
- best used by 7/03/14
- Lot: 3022
- best used by 7/28/14
- b) 10 mL: Lot: 2166
- best used by 5/26/14
- Lot: 2297
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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