Glutathione Injection Recalled for Potential Non-Sterility
Pharmacy Creations is recalling 12 vials of Glutathione 100mg/mL Sterile Injection due to failing sterility test results.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Pharmacy Creations is recalling 12 vials of Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial. The recall was initiated because failing sterility results were obtained from the firm's contract testing facility, indicating that the products may not be sterile.
The affected product is identified by Lot # 05122014@4 with an expiration date of 09/09/2014. The product was distributed directly to patients and physicians in Florida, New Jersey, New York, and Puerto Rico.
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 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
- Manufacturer
- Pharmacy Creations
- Category
- Drug — Sterile Injection
- Hazard
- Affected units
- 12
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 #: 05122014@4
- Exp 09/09/2014
Distribution
Part of a larger recall action
This product is one of 4 recalled by Pharmacy Creations 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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