D-1019-2013 Class II Terminated
FDA drug recall D-1019-2013 was initiated by Creative Compounds on August 23, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 16, 2013). Affected quantity: 16 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2013
- Initiation Date
- August 23, 2013
- Termination Date
- September 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 vials
Product Description
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
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.
Distribution Pattern
Oregon and Washington
Code Information
Lot #: 20130715@12, Exp10/13/2013