D-1210-2016 Class II Terminated

Recalled by Medaus, Inc. — Birmingham, AL

FDA drug recall D-1210-2016 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: 14000 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
14000 mL in Vials

Product Description

LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 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 #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16. b) Lot #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1210-2016
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.