FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
FDA is recalling 2 syringes of injectable glutathione from Moses Lake Professional Pharmacy because the sterility of the compounded drug cannot be assured.
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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a structural or sterility defect in an injectable drug, which poses a risk of significant injury, is classified as Severe (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling two syringes of GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 mL, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is being conducted because there is a lack of assurance of sterility for the sterile human compounded drugs within their expiry date.
The affected product is a prescription-only injectable solution. The recall covers two syringes with lot codes t03192015@31 and t04272015@5. The distribution pattern for this recall 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 FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 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 — Injectable Solution
- 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)
- t03192015@31
- t04272015@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.
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