Drugs being pulled off of shelves because of bad odors is not a rarity. The FDA even addresses the topic in a pharma manufacturing Q&A. It has happened again, and this time, it involves nearly 600,000 bottles of Glenmark Pharmaceuticals' generic version of the Merck ($MRK) blockbuster asthma med, Singulair.
The company is voluntarily recalling 29 lots of its montelukast sodium tablets. It decided to retrieve them after pharmacists and consumers noticed the bottles had "an off-odor, described as moldy, musty or fishy."
The company said when it checked out the smelly containers, it discovered bottles from one of its multiple suppliers had "trace levels" of tribromoanisole (TBA) and trichloroanisole (TCA). The FDA says TBA is sometimes used as a preservative in wood used in pallets. Glenmark tells the Hindu Business Line there there is no danger from the drugs but that it is now shipping batches in alternative bottles.
Smelly products were one of a myriad of problems tied to recalls of over-the-counter products produced at a Johnson & Johnson ($JNJ) plant a couple of years ago. Pfizer ($PFE) last year recalled more than 650,000 bottles of Advil gel tabs from stores because they had a strong odor. Indian generics maker Dr. Reddy's Laboratories last year recalled about 50,000 bottles of citalopram, the generic of Forest Laboratories' ($FRX) antidepressant, Celexa, because consumers complained they smelled of garlic.
Glenmark had another recall last year involving packaging. In that case, it recalled 7 lots of norgestimate and ethinyl estradiol birth control pills manufactured in India because the pills were rotated 180 degrees in the card, mixing up the order in which they were to be taken.
- here's the FDA notice
- see Glenmark's recall notice
- here's the FDA Q&A
- read the Economic Times story