Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns
Guardian Pharmacy Services is recalling 100 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.
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. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance) corresponds to a severity score of 4 (Severe).
Plain-English summary
Guardian Pharmacy Services is recalling 100 50-mL vials of compounded Glutathione 200 mg/mL. The product is prescription-only and was distributed in Texas. The specific lot number is 59097:42, with a use-by date of 07/23/2018.
The recall was initiated because of a lack of sterility assurance. This means the product may not be sterile, which poses a risk of infection if administered.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded Injectable
- Hazard
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)
- Lot: 59097:42 Use By: 07/23/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services 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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