Tylenol recall- What about generics?

Tylenol is recalling more of its product after a “musty smell” was detected in some of the Tylenol 8 hour release caps.

What I’m wondering is, do we often hear about generics being recalled? Is the scrutiny given generic drugs truly as close as name-brand products? It could be selective memory on my part, but I don’t seem to remember many product recalls that focus on the generic substitutes for name-brand meds.

Because the recall is BS. Enough people call to complain and get free stuff, the FDA tells Tylenol they should do a recall even though no problem is proven.

Many different companies and products are using those same stinky pallets, but people are paranoid about Tylenol because of the previous press and recalls, and go around sniffing their pill bottles (which all smell like crap). Generics don’t have an 800 number for people to call and complain about a ‘moldy odor’.

Generics are regulated by the FDA (or other country’s equivalent) the same way brand name products are. Generic products have been shown to be (statistically) identical (bioequivalent) to the brand name product; the difference in cost is related to built-in R&D recovery costs rather than quality.

In the 4 years I worked in the industry in Canada I was personally involved in no less than 3 audits by the FDA and 4 by Health Canada, while the companies I worked for had more audit reviews of particular product applications/approvals throughout that time. The first company I worked for was a contract lab working on both brand and generic products, the second company was generics only.

Generic companies do have product recalls, and any bottle/box of generic product will have contact information for the manufacturer and/or distributor printed on it. Alternatively, issues can be reported directly to the FDA or equivalent. The reason you don’t hear about it as much is that there’s no brand recognition - few people know the name “ratiopharm” or “Apotex” but everyone knows “Pfizer” and “Tylenol”. I have personally done investigative lab work on at least one product recall (not an OTC product; another reason why you’d hear less about them).

Recent recalls of generic products found with a quick google of [company name]+“recall”:
Timolol Ophthalmic Solution in 0.25% and 0.5% - Sandoz
Fentanyl Transdermal patches - Sandoz
Apo-Amilzide, Apo-Meloxicam, Apo-Ranitidine - Apotex
ratio-Morphine SR 15 mg, 30 mg and 60 mg tablets - ratiopharm

In fact, the Canadian list of recalled products can be found here. The FDA list is here.

From what I understand, medicines are not like other generics, in that they are usually not also made by the brand name’s manufacturer. In fact, I’ve never even heard of a rebranded generic in medicine.

It would therefore be unlikely that a batch of bad Tylenol would have ever been used as a generic.

That has been my experience too - one batch of a drug is not split into two sets of bottles, one brand name and one generic. However, there are manufacturing facilities that make their own generic drugs and manufacture the brand name products under contract, or manufacture the generic drug for two or more companies under contract (Patheon, for one example, and I think Apotex and Pharmascience do as well, though I’m not sure about them).

Companies that manufacture two versions of the “same” drug will do so using different sets of methods (the recipes may vary somewhat), different documentation, different batch records, etc in the same way that it would be a different process to manufacture a batch of Drug A and a batch of Drug B. In fact, it might even involve different staff entirely, not allowing the analysts and technicians that work on a contract for Company A to do work on the competitor product of Company B in order to satisfy trade secret/disclosure/other rules or contract agreements. Where I worked, that was the case - I could not, under any circumstances, view any method, data records, lab notebooks or other documentation pertaining to a product being tested in another group, since I was working on a competitor’s version of it.

In a purely hypothetical example (I know no details about this current Tylenol recall) if lots 10012 to 10014 of Tylenol 100mg were being recalled due to X issue, and another product (either acetaminophen or another drug) was manufactured around the same time on the same equipment, it is possible that the other drug may be recalled as well if there is reason to believe that it is the equipment, labour or process that is the source of the issue.

Usually a recall isn’t made until representative samples of an affected lot are tested and the issue is confirmed (which can be very quick) and a plausible list of affected lots and equipment used has been verified. If it looks like the error is with the drug product itself, then only the drug will be recalled. If it looks like the error is with the manufacturing equipment/technician activities, then other products may be recalled at the same time.

For example, the voluntary recall of Children’s Tylenol, Infant Motrin and Children’s Zyrtec were simply due to poor ink used on the labels, rather than a problem with the drug itself.

This particular recall is only on 50 count bottles of brand Tylenol, and only one lot (lot number BCM155 if interested). The recall was issued due to “a musty odor”, which was the reason for the large recall earlier this year, which ended up being because of contamination with 2,4,6-tribromoanisole, which was a byproduct of a anti-fungal that was used on the packing material. This recall is “most likely” due to the same contamination.

The company that makes Tylenol, and some other popular brands, does not make any of the generic drugs, so those are totally safe. Most OTC generic drugs are produced by multiple companies, or at different plants (or as mnemosyne said), so they don’t get recalled when the brand does. There has been recalls of certain generic drugs before, but they are normally more limited so don’t make the news as much as the brands do. When there is a generic recall, it would be more like all Wallgreens, or CVS, or RiteAid acetaminophen tablets, and only be limited to one distribution source, so won’t normally enter the public consciousness.

Oh, and as mnemosyne also said, recalls of generic prescription medications is not unknown. I’ve had to go through the shelfs and check expiration dates and lot numbers on recalls more then I remember.

There are medications out there that are sold as a “generic” but is actually just the brand medication. Normally happens when a drug first goes off patent. The current medication that I can think of is Protonix, which has the brand tablets (even still say “protonix” on the tablet) in generic packaging at a generic price.

Looking in my medicine cabinet, I have OTC generics from Perrigo, Taro, Actavis, Novartis, and Sight Savers (Bausch & Lomb); all have 1-800 contact information in their FDA labeling. IME the large pharmacy and discount retail chains require their generics manufacturers to provide toll-free contact information on the FDA labeling (though such information is optional under FDA rules).

Though it should be noted that this wasn’t the most recent recall, and affected only professional samples. The broader recall of Children’s Tylenol, Infant Motrin, and Children’s Zyrtec a month later was due to inconsistent and possibly elevated levels of active ingredients, unknown foreign particles, and/or unlisted inactive ingredients.

Yes, I know. I just chose a random one to illustrate what I meant:)