D-1198-2016 Class II Terminated
FDA drug recall D-1198-2016 was initiated by Medaus, Inc. on May 13, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 16, 2017). Affected quantity: 5000 mL in Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- May 13, 2016
- Termination Date
- June 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5000 mL in Vials
Product Description
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot #: 160222-28, BUD: 05/22/16; Lot #: 160302-63, BUD: 05/31/16