D-1245-2016 Class II Terminated
FDA drug recall D-1245-2016 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: 150 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
- 150 mL in Vials
Product Description
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 160119-12, BUD: 07/17/16. b) Lot #: 160119-12, BUD: 07/17/16. c) Lot #: 160119-12, BUD: 07/17/16. d) Lot #: 160119-12, BUD: 07/17/16. e) Lot #: 160119-12, BUD: 07/17/16.