Reported Aug 22, 2012 · Terminated

DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE…

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?

7 of 7 products · 12 lot codes

Recalled lot codes, grouped by product number
Product number	Lot codes and dates
`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 #: 0400257
Amount recalled: 1 unit

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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Franck's Lab Inc., d.b.a. Franck's Compounding… recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

All recall categories · Browse the whole archive