D-1243-2016 Class II Terminated
FDA drug recall D-1243-2016 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: 20 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
- 20 mL in Vials
Product Description
TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 160302-71, BUD: 08/29/16. b) Lot #: 151207-8, BUD: 06/04/16; Lot #: 160106-34, BUD: 07/04/16; Lot #: 160208-22, BUD: 08/16/16.