FDA Recalls Unapproved Saluta Reduced Glutathione Injection Powder
Flawless Beauty LLC is recalling Saluta (reduced glutathione) Powder for Injection because it was marketed without an approved NDA/ANDA and is labeled for use as an antidote.
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, which corresponds to a 'Severe' rating under the rubric for significant health risks associated with unapproved parenteral products.
Plain-English summary
Flawless Beauty LLC is recalling Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box. The product is exclusively distributed by QAF Pharmaceuticals Inc. in the Philippines and manufactured by Shandong Luye Pharmaceutical Co. Ltd. in China. The recall covers specific lots with expiration dates in 2015.
The FDA issued this recall because the parenteral product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product is labeled for use as an antidote, which is not an approved indication for this unapproved drug.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manuf
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Injection
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 (4)
- Lot #: 201302275
- Exp 01/20/15
- 201308384
- Exp 10/19/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flawless Beauty 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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