The Recall Desk
SevereFDA (Drugs)·D-1019-2013·Announced 2013-09-18

FDA Recalls Glutathione Injectable Due to Potential Bacterial Contamination

Creative Compounds is recalling 16 vials of Glutathione 100 mg/mL Injectable due to out-of-specification results and potential bacterial contamination.

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 potential bacterial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with significant risk).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Glutathione 100 mg/mL Injectable, 100mL Vial, manufactured by Creative Compounds in Wilsonville, Oregon. The recall involves 16 vials with Lot # 20130715@12 and an expiration date of 10/13/2013.

The recall was initiated because the product yielded out-of-specification results and there is a potential for bacterial contamination. The source text notes that the product was reported as passing by a contract laboratory, despite these findings.

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, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Manufacturer
Creative Compounds
Category
Drug — Injectable
Hazard
Affected units
16

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 #: 20130715@12
  • Exp10/13/2013

Distribution

Distributed in 2 states:

Related recalls

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