FDA Recalls Papaverine and Phentolamine Injectable Solution Due to Sterility Concerns
Moses Lake Professional Pharmacy is recalling 8 syringes of Papaverine/Phentolamine Injectable Solution because the agency cannot assure the sterility of the compounded drug.
What this means for you
Illness, injury, or structural failure has been reported. 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 with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine/Phentolamine, Injectable Solution, 30MG/1MG/ML, 10 mL syringe. The product is a prescription-only medication compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within their expiry date are affected by this issue. A total of 8 syringes are involved in this recall.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/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
- 8
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 (8)
- t09172014@29
- t08252014@1
- t06082015@10
- t03032015@26
- t02272015@23
- t01232015@12
- t01122015@36
- t05132015@15
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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