D-1168-2016 Class II Terminated
FDA drug recall D-1168-2016 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: 380 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
- 380 mL in Vials
Product Description
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S. Nationwide, Japan, and New Zealand.
Code Information
Lot #: 160115-3, BUD: 06/11/16; Lot #: 160202-10, BUD: 06/11/16; Lot #: 160204-43, BUD: 06/11/16; Lot #: 160223-3, BUD: 06/11/16; Lot #: 160307-26, BUD: 06/11/16; Lot #: 160309-1, BUD: 06/11/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1168-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026