Wise Pharmacy Recalls Gentamicin Irrigation Solution Due to Processing Controls
Wise Pharmacy is recalling Gentamicin Irrigation Solution due to a lack of processing controls. The affected product was distributed in Colorado, Texas, and Wyoming.
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, which typically involves a temporary or medically reversible adverse health consequence. The source text cites 'Lack of Processing Controls' without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Wise Pharmacy, located in Littleton, Colorado, is recalling Gentamicin (GU) Irrigation 240 mg/500 mL Solution. The product is packaged in 250 mL containers and is compounded for prescription use only. The recall is being conducted due to a lack of processing controls.
The affected product is identified by Lot # 7179N and has an expiration date of July 16, 2019. The recall number is D-1570-2019. The product was distributed in Colorado, Texas, and Wyoming.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Manufacturer
- Wise Pharmacy
- Category
- Drug — Compounded Prescription
- Hazard
- Affected units
- 1
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 (2)
- Lot #: 7179N
- Exp 7/16/2019
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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