FDA Recalls Papaverine/Phentolamine/Prostaglandin Injectable Solution Due to Sterility Concerns
JD & SN Inc. is recalling 2 syringes of Papaverine/Phentolamine/Prostaglandin Injectable Solution because the agency cannot assure the sterility of the compounded drug.
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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly when involving sterile injectable drugs where sterility assurance is compromised.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Papaverine/Phentolamine/Prostaglandin Injectable Solution, 9 mg/1 mg/10 mcg/mL, 10 mL syringe. The product is compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recall is being conducted due to a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within their expiry dates are affected by this issue. The recall covers 2 syringes of the product, which are distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The FDA classifies this as a Class II recall, meaning the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/10 MCG/ML, 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
- Hazard
- Affected units
- 2
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)
- t10282014@28
- t02272015@9
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.
See all 101 products in this recall →Related recalls
Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy
See all →- SevereFDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
- SevereFDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
- SevereMoses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
- SevereMoses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
- SevereFDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighInjectable Drug Recalled Over Failure to Assure Product Sterility
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Compounded Injectable Drug Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- HighPrescription Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Papaverine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12