Glutathione Injection (Pharmacy Creations) – Non-Sterile Risk (2014)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Brand
Pharmacy Creations
Lot Codes / Batch Numbers
Lot #: 05122014@4, Exp 09/09/2014
Products Sold
Lot #: 05122014@4, Exp 09/09/2014
Pharmacy Creations is recalling Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph due to Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be ste. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IN, NJ, NY, PR
Page updated: Jan 12, 2026