D-0306-2015 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- September 5, 2014
- Termination Date
- July 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 vials
Product Description
Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Reason for Recall
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Distribution Pattern
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Code Information
Lot #: 05122014@4, Exp 09/09/2014