Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1488-2012

D-1488-2012 Class II Terminated

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

FDA drug recall D-1488-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 25, 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 because FDA environmental sampling revealed the presence… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 86 units.

Recall Details

Product Type
Drugs
Report Date
Aug 22, 2012
Initiation Date
May 25, 2012
Termination Date
Aug 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
86 units

Product Description

CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20 MLS, 40 ML; CYANOCOBALMIN ***(VIT B-12) 25X1ML 1000MCG/ML INJECTABLE 50 MLS (24 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 because 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, and West Indies

Code Information

Rx #'s: 0387434 0387442 0373259 0379220 0379925 0381812 0382155 0389481 0391043 0391912 0392598 0393303 0397302 0368903 0385563 0377621 0389560 0376591 0387169 0375580 0388039 0381499 0387434 0387442 0368903 0398369 0385601 0381154 0382450 0395591 0399380 0400168 0401501 0375406 0388039 0370251 0379203 0380414 0373568 0373668 0379036 0376722 0380943 0381499 0384292 0388741 0395917 0373742 0387702 0389521 0373742 0401945 0409583 0404840 0407920 0407921 0407922 0407923 0407925 0407926 0407928 0407931 0407933 0407935 0403019 0406664

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1488-2012
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)

FDA data resources