D-1174-2016 Class II Terminated

Recalled by Medaus, Inc. — Birmingham, AL

FDA drug recall D-1174-2016 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: 62 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
62 mL in Vials

Product Description

B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S. Nationwide, Japan, and New Zealand.

Code Information

a) Lot #: 160209-24, BUD: 05/28/16. b) Lot #: 160106-12, BUD: 05/28/16; Lot #: 160222-70, BUD: 05/28/16. c) Lot #: 160129-9, BUD: 05/28/16; Lot #: 160202-16, BUD: 05/28/16.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1174-2016
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.