Reported Aug 22, 2012 · Terminated

DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS;…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138

Is this the product you have?

  • DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML
Lot codes and dates
  • Rx #'s:
    • 0406046
    • 0397385
    • 0366980
    • 0395509
    • 0387345
    • 0387381
    • 0387586
    • 0387752
    • 0391041
    • 0391584
    • 0394112
    • 0394246
    • 0395288
    • 0397054
    • 0397946
    • 0399555
    • 0400910
    • 0401208
    • 0403442
    • 0404123
    • 0408115
    • 0388847
    • 0388144
    • 0388144
    • 0395892
    • 0389202
    • 0373332
    • 0378850
    • 0388550
    • 0392222
    • 0373332
    • 0378850
    • 0388550
    • 0373332
    • 0373332
    • 0378850
    • 0358046
    • 0376175
    • 0392337
    • 0375442
    • 0392337
    • 0377047
    • 0381838
    • 0388945
    • 0407636
    • 0371528
    • 0375458
    • 0375458
    • 0400150
    • 0368414
    • 0366367
    • 0389059
    • 0392819
    • 0407227
    • 0368231
    • 0390906
    • 0405998
    • 0364593
    • 0409797
    • 0364593
Amount recalled
73 units

This recall covers 198 products

The agency filed one notice per product. You are reading one of them; the other 197 are below.

185 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 13, 2014 · Data as of Sep 19, 5:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.