D-1190-2016 Class II Terminated
FDA drug recall D-1190-2016 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: 210 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
- 210 mL in Vials
Product Description
HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot #: 160202-12, BUD: 07/11/16; Lot #: 160204-10, BUD: 07/11/16; Lot #: 160210-70, BUD: 07/11/16; Lot #: 160215-11, BUD: 07/11/16; Lot #: 160222-17, BUD: 07/11/16; Lot #: 160223-64, BUD: 07/11/16; Lot #: 160224-67, BUD: 07/11/16; Lot #: 160307-28, BUD: 07/11/16; Lot #: 160308-1, BUD: 07/11/16; Lot #: 160309-3, BUD: 07/11/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1190-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026