FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable glutathione vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile injectable products where sterility assurance is compromised, representing a significant risk of harm.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vials. The recall involves 2,200 mL of product distributed in Oregon and Washington.
The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy. The affected lots are identified by Lot # 20140721@25/00 with a discard date of 11/18/2014, and Lot # 20140902@47 with a discard date of 12/31/2014.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GLUTATHIONE with preservative, 100mg/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 (4)
- Lot #: 20140721@25/00
- discard date: 11/18/2014
- Lot #: 20140902@47
- discard date: 12/31/2014.
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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