FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable glutathione vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
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 involves a lack of sterility assurance in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 100 mL glass vials of injectable glutathione (100 mg/mL). The recall involves Lot # 20140718@4 with a discard date of 10/16/2014. The total quantity involved is 900 mL.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility assurance of sterile products compounded by the pharmacy. The agency classification for this recall is Class II.
The affected product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- GLUTATHIONE, 100 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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)
- Lot #: 20140718@4
- discard date: 10/16/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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