AstraZeneca packing mistakes lead to two recalls, one for BMS

Bristol-Myers Squibb is recalling one lot of its Eliquis 5-mg tablets in the U.S. that was manufactured by AstraZeneca's contract unit because a bottle was found to have 2.5-mg tablets in it.

Bristol-Myers Squibb is recalling a lot of its anticoagulant Eliquis after a customer got a bottle that contained tablets that were half the prescribed dose. The product, however, was manufactured for BMS by AstraZeneca, and it is the second recall in recent weeks tied to packaging issues with the U.K. drugmaker.

Bristol-Myers said on Tuesday that it is voluntarily recalling to the customer level one lot of its Eliquis 5-mg tablets after a patient reported getting a bottle that contained 2.5-mg tablets. BMS pointed out that taking a half-dose would increase the risk of having any of the problems, namely stroke, blood clots, or atrial fibrillation, for which patients might have been prescribed the blood thinner.

The tablets look entirely different, with the 5-mg dose being oval, pink, and having a 5 stamped on one side and 894 on the other. The 2.5-mg pills are round, yellow and have 2 1/2 stamped on one side and 893 on the other.

A BMS spokesperson said that the tablets were manufactured by AstraZeneca’s contract manufacturing unit at a plant in Mount Vernon, Indiana.

The recall comes less than two weeks after AstraZeneca issued a voluntary recall for one lot of sample bottles containing eight 90-mg tablets of its own cardiovascular drug Brilinta. That came after one bottle was discovered to also contain 200-mg tablets of AstraZeneca’s gout drug Zurampic.  

The danger, AstraZeneca said, is that the unintentional use of Zurampic could lead to kidney problems, including renal failure, which is more acute when the drug is taken alone instead of with a xanthine oxidase inhibitor as it should be.

The danger of missing a dose of Brilinta is that it would increase the risk of a heart attack or stroke or increase the chance of a blood clot in patients with stents.

Again, the two drugs look entirely different, with Brilinta 90-mg tablets being round, yellow and imprinted with 90 above a T on one side of the pill. Zurampic 200-mg pills are blue in color and elliptical/oval in shape. They are imprinted with LES200 on one side.