Recalls / Class I
Class ID-0306-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
- Affected lot / code info
- Lot #: 05122014@4, Exp 09/09/2014
Why it was recalled
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Recalling firm
- Firm
- Pharmacy Creations
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 540 Route Ten West, Randolph, New Jersey 07869
Distribution
- Quantity
- 12 vials
- Distribution pattern
- Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Timeline
- Recall initiated
- 2014-09-05
- FDA classified
- 2014-12-19
- Posted by FDA
- 2014-12-31
- Terminated
- 2015-07-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0306-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.