Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1616-2012

D-1616-2012 Class II Terminated

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

FDA drug recall D-1616-2012 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). Affected quantity: 63 units.

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 Quantity: 63 units

Product Description

SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS)

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: 0386512 0388165 0390153 0392066 0392315 0392317 0384766 0392082 0392094 0379483 0385383 0393729 0397989 0398600 0406470 0407865 0407875 0409041 0410198 0386262 0399600 0386262 0408795 0395274 0395279 0395285 0376062 0389403 0399790 0400511 0400527 0401472 0402407 0402536 0403638 0406466 0406692 0407272 0405789 0394350 0402541 0394350 0392062 0392062

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1616-2012
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.

Other recalls by Franck's Lab Inc., D.B.A. Franck's Compounding Lab

D-1468-2012 Class II — BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT… (May 25, 2012)
D-1512-2012 Class II — EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM… (May 25, 2012)
D-1532-2012 Class II — HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT) (May 25, 2012)
D-1516-2012 Class II — ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML… (May 25, 2012)
D-1530-2012 Class II — GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML… (May 25, 2012)
D-1453-2012 Class II — ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML… (May 25, 2012)
D-1541-2012 Class II — HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL… (May 25, 2012)
D-1496-2012 Class II — DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT) (May 25, 2012)
D-1478-2012 Class II — BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML… (May 25, 2012)
D-1494-2012 Class II — CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A)… (May 25, 2012)