FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is regulatory (unapproved/unregistered) rather than a specific physical defect or contamination, fitting the Moderate criteria for minor labeling or regulatory errors.
Plain-English summary
Medical Supply Liquidators LLC is recalling Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials. The product is sterile and intended for intramuscular (IM) or deep subcutaneous (SQ) use. It was manufactured by CB Inc. for Sunshine Labs.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the manufacturing firm is not registered with the FDA as a drug manufacturer. The recall covers all lot numbers and expiration dates.
The product was distributed nationwide and to Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
- Manufacturer
- Medical Supply Liquidators Llc
- Category
- Drug — 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 (1)
- All lot numbers and exp dates
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medical Supply Liquidators Llc 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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