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 sterility assurance.
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 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, Phentolamine Mesylate, and Alprostadil. The recall is being conducted because of a lack of assurance of sterility in these aseptically filled 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 June 4, 2014, to July 15, 2014. The distribution pattern for these products is nationwide.
Consumers and healthcare providers should stop using the affected products and contact John W Hollis Inc or their healthcare provider for further instructions.
The recalled product
- Product
- Papaverine HCl 30 mg, Phentolamine Mesylate 1 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
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 (9)
- a) 5 mL: Lot: 2670 best used by 7/02/14
- Lot 2855
- best used by 7/15/14
- b) 10 mL: Lot: 2303
- best used by 6/04/14
- Lot: 2343
- best used by 6/08/14
- Lot: 2600
- best used by 6/29/14
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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