Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1574-2012

D-1574-2012 Class II Terminated

Recalled by Franck's Lab Inc., D.B.A. Franck's Compounding Lab — Ocala, FL

FDA drug recall D-1574-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 21, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of… The recall status is terminated (terminated Aug 15, 2014).

Recall Details

Product Type: Drugs
Report Date: Aug 22, 2012
Initiation Date: May 21, 2012
Termination Date: Aug 15, 2014
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS

Reason for Recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Code Information

Rx #'s: 0369092 0390078 0388491 0404406 0399651 0373092

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1574-2012
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

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

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