Beware contact lens wearers…new recall announced.
Jan 30th, 2008 | By Michael L. Saile, Jr., Esq. | Category: Blogs, Dangerous ProductsNuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.
Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled “Eye Drops Caution: Do Not Use With Implants” or “Eye/Ear Wash” are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.
No illnesses or injuries have been reported to date.
The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them.
The author of this Blog, Philadelphia car accident lawyer, Michael L. Saile, Jr., Esq. of Saile & Saile LLP, Attorneys-at-Law focuses his practice on fighting for plaintiffs’ personal injury and car accident victim’s rights in both Pennsylvania and New Jersey. We handle all serious injury cases including, car accidents (both limited and full tort), wrongful death, slip & fall downs, construction accidents, Septa, NJ Transit, and other cases other cases. We are located just outside of Philadelphia in lower Bucks County. We also handle Philadelphia plaintiffs’ personal injury and car accident cases. Please visit our personal injury only website at www.pa-nj-injurylawyer.com for more injury information.
well, 500 units seems like a very small run.
I wonder if it was stability testing on retained units that showed this. Maybe even accelerated stability testing.
There are a few things to look at.
Was this a new formula?
review of process validation testing and packaging validation testing.
review of stability testing data and stability samples still in chamber.
review of the actual batch testing
inspection of bulk and finished goods retain samples
review of raw material testing for each raw used in the batch
batch record review, was the process to make the batch followed? also processor interviews here.
review of cleaning validation performed for this formula on each piece of procee equipment and packaging equipment- includes trace analysis of active, as well as micro
review of micobilogy testing on packaging components
all micro , chemistry, physical, and qa testing for everything related to the formula.
lol, this is nothing
if there was a problem with the batch or formula, it should have been found before batch release.
the fact that it got to market tellsc me either one of the labs messed up, or it is a stabilty issue.
for the precipitate i would lean towards a stability issue on this type of product, ive seen it before in drops, and it is defintively a formulation problem.
as far as micro, the fda should go through all records of micro testing, cleaving procedures and all things like that.
belive me, this is a common occurance and should have been found before the product out the door…
i habe been involved in 1000′s of these types of investigations
called, oosi, out of spec investigation
investigations like this are highhly political within the company.
but it is important to find out exactly what happened to prevent it from happening again.
the underlying cause in something like this could be processor error, but the exact error needs to be pinned down, bad raw material, contaminated raw- even an inspection of the raw in the warehouse is needed, or possible a formulation error– the formula does not hiold up under certain environmental or time based conditions.
everything needs to be looked at and investigated , reports written by many people, and a reason found for the batch failure!
the other possibility is this was a consumer complaint sample sent back to the manufactuer by the retailer.
The compnay keeps records of consumer complaints and the FDA always asked to see these records, what was done, ect…
The manufacturer may niot have crossed all the T’s or dotted all the eyes on the consumern complaint investigation, .. therefore agreeded to a recall as a good faith move FDA inspector.
Consumer compliants all always high on the list for the FDA to ask to see on the first day of entering a manufacturing facility like this.
If it is a consumer complaint sample, and absoutley nothing can be found in the investigation i outlined in the first 2 posts… all bets are off.
The bottle could have been opened, sat in someones bathroom, subjected to hot steam from a shower, and a ton of general bathroom bateria.
Identifying the kind of bacteria is imortant,.. microbiology is not my area though, any microbilogists out there?
As i said, if it is a consumer complaint of this nature, the recall may have came out of the need for a full investigation, and not necessarily because anything was wrong with the batch or final product.
FDA are real sticklers and this sounds like a small company , as only a 500 piece batch, that maybe they do not have the personel like a huge pharma compnay would to run investigations on a 24/7 daily basis as companies I have workled in have.
the last place i worked at would fill about 15 million units a month, just in one department, maybe covering 200 different formulas give or take. this was the area i worked in.
typically, the first 500 pieces off any line on any shift would be thrown out as garbage, another 500 or so taken throughout the run, on a line, on a shift, and divided up for testing among the chemistry lab, micro lab, and qa lab, as well as a bunch for retain.
the area i worked in, called treatment, had 37 lines on the packageing floor, maybe 15-18 running at any one time, 24/7. while the other lines were being changed over and sanatized.
in the processing area for treatment, we averaged manufacturing about 15-18 batches a day, 24/7.
the amount of testing for both bulk from processing and finished goods from the treatment floor was a lot, so much.
everyday, we would find 1-3 batches that had some kind of problem, problems ranging from viscosity, ph, emulsion, appearance, low/high presevatives, low/high actives.
we tracked all the problems, did investigations,everyday, and the factory destroyed a lot of bulk that could not be saved, millions of dollars worth just in cost to make.
i was in charge of all the testing and initiating investigations, keeping my bosses and all departments informed, releasing bulk and finished goods, instrument calibration and validation, SAFTEY, training chemists, cross training, ordering supplies, record keeping, batch record filing, retain room of bulk samples, overseeing the entering of all results into the computer system, assigning the work, reviewing the testing, notebooks, and chromatograms, troubleshooting instruments, and responding to about 30-40 emails a day from people throughout the company.
I had 8 chemists under me, 3 on first shift, 3 on 2nd shift, and 2 on 3rd shift, and we worked 28 of 31 days every month for years.
I was directly overseeing all 3 shifts, my desk right in the lab.
by the time i was put in this job position, i had 17 years experience on the bench in several different companies, including 3 at this company, and i was relied upon heavily by the company in all of the areas, especially my expertise in analytical instrumentation, software driven analytical instrumentation.
the work got to be so much, the company trying to push out more and more product, on an ever increasing monthly goal, that every chemist and myself had no time to do anything but task after task, every second of everyday… in perfect way, in perfect order, and fast fast fast… and we did it perfect and fast,
by the end of my first year in this position, the company, various departments, from the president down, could no longer blame the lab for delays of any kind… so they started looking at where the real problems were, in the ordering and stocking of components, bottles and jars, raw material delays, and processing delays.
by the end of my 2nd year in this position, the company had adressed these issues and all departments were working together , exchanging information, as a team. this lead to more burden on the lab, as the other departments caught up.
at the same time, the company decided to increase the amount of new products going on the market, and in an agressive way, with 3-5 new formulas every week!, This meant for us a ton of more validation testing for each formula, as well as new methods to learn, with even method transfer protocol from r and d to be performed sometimes.
by the end of the 3rd year in this position, the lab needed one more chemist for each shift and a suspervisor in the lab for each shift…. but the company would not do it. the company wanted to continue to work us ragged, 28 days a month, of non stop , every second of time, involved in never ending tasks,…. something was going to give, breakdown.
i am looking forward to getting back on the bench, running a hplc or 2 during my day, maybe a little aa, uv, ir, gc, and get back to just performing what i am an expert at, analysis, and documentation of my an alysis.
i am sure i can help a company with not only me analytical expertise, but also my wisdom… in the right situation.