FDA Recalls Pyridoxine HCL Injectable Solution Due to Sterility Concerns
The FDA is recalling 6 syringes of Pyridoxine HCL injectable solution from JD & SN Inc. due to a lack of assurance of sterility.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Pyridoxine HCL, injectable Solution, 100 mg/mL, 30mL syringe. The product is prescription-only and was compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The recall involves 6 syringes of the medication.
The reason for the recall is a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within the expiry date are affected by this issue. The distribution pattern for these products is listed as nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PYRIDOXINE HCL, injectable Solution, 100 mg/mL, 30mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Injectable Solution
- Affected units
- 6
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)
- t05292015@5
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
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