FDA Recalls Compounded Injectable Glutathione Due to Sterility Concerns
FDA is recalling compounded injectable glutathione from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.
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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death from infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of GLUTATHIONE MDV, Injectable Solution, 200 mg/mL. The product is compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, in Moses Lake, Washington. The recall involves syringes of 60 mL, 90 mL, 100 mL, and 150 mL sizes.
The recall was initiated because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The agency has classified this as a Class II recall. The affected product is prescription-only and was distributed nationwide.
Patients who have received this medication should consult their healthcare provider for guidance on next steps. The FDA advises consumers to check with their pharmacist or doctor regarding the specific lots involved in this recall.
The recalled product
- Product
- GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, 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
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 (11)
- t12012014@6
- t09182014@28
- t09162014@31
- t09162014@22
- t08292014@6
- t08122014@26
- t07222014@15
- t05262015@13
- t01192015@11
- t05082015@4
- t04202015@13
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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