Wise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials
Wise Pharmacy is recalling 97 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of processing controls, which is a quality control issue. The source text does not report any illnesses or injuries, and the hazard is theoretical rather than confirmed harm, fitting the criteria for a moderate severity score.
Plain-English summary
Wise Pharmacy, located in Littleton, Colorado, is recalling 97 vials of Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial. The product is prescription-only and was compounded by the pharmacy. The recall was initiated due to a lack of processing controls.
The affected product includes vials with the following lot numbers and expiration dates: Lot 5620N (Exp 7/16/2019), Lot 6221N (Exp 8/31/2019), and Lot 6952N (Exp 10/16/2019). The product was distributed in Colorado, Texas, and Wyoming.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Manufacturer
- Wise Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 97
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)
- Lot #: 5620N
- Exp 7/16/2019
- 6221N
- Exp 8/31/2019
- 6952N
- Exp 10/16/2019
Distribution
Part of a larger recall action
This product is one of 11 recalled by Wise Pharmacy 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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