Moses Lake Pharmacy Recalls Injectable Solution Due to Sterility Concerns
JD & SN Inc. is recalling a compounded injectable solution because the FDA could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.
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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an injectable drug poses a significant risk of serious harm, aligning with the Severe classification for Class II drug recalls.
Plain-English summary
JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling a compounded injectable solution containing papaverine, phentolamine, atropine, and prostaglandin. The product is a 10 mL syringe intended for prescription use only. The recall was initiated because the FDA could not ensure the sterility of the compounded drug within its expiration date.
The recall covers the specific product identified by the code t03312015@8. The distribution pattern is listed as nationwide, though the specific quantity of units affected is not stated in the source text. No illnesses or injuries have been reported in the provided source material.
Patients who have received this medication should stop using it and contact their healthcare provider for further instructions. The recalling firm is JD & SN Inc., located in Moses Lake, Washington.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 30 MG/2 MG/0. 1MG/20MCG, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Compounded Injectable
- 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 (1)
- t03312015@8
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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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