D-1241-2016 Class II Terminated
FDA drug recall D-1241-2016 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 Jun 16, 2017). Affected quantity: 500 mL in Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2016
- Initiation Date
- May 13, 2016
- Termination Date
- Jun 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 mL in Vials
Product Description
TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
a) Lot #: 160115-17, BUD: 07/13/16. b) Lot #: 160115-17, BUD: 07/13/16. c) Lot #: 160115-17, BUD: 07/13/16. d) Lot #: 160115-17, BUD: 07/13/16.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1241-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026