Status
Terminated
Drug Enforcement D-1019-2013
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Classification
Class II
Report Date
September 18, 2013
Termination Date
September 16, 2013
Product Information
- Product description
- Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
- Product quantity
- 16 vials
- Reason for recall
- Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Oregon and Washington
Location & Firm
- Recalling firm
- Creative Compounds
- Address
-
8560 Sw Salish Ln Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1019-2013
- Event ID
- 66084
- Recall initiation date
- August 23, 2013
- Center classification date
- September 10, 2013
- Code info
- Lot #: 20130715@12, Exp10/13/2013
- More code info
- —