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Manufacture Small Molecules

Recall Roundup

A number of companies have announced recalls in recent weeks, stemming from a range of problems sterility blunders, leaky containers, packaging mishaps, crumbling tablets and more.

One of the biggest recalls of late comes from Baxter, which has had a string of problems with its 0.9% sodium chloride (saline) intravenous solutions in the US. The most recent recall, in July, affected two lots of saline and was attributed to the potential presence of ‘particulate matter’ – which turned out to be insects. A few weeks earlier, the company had to recall 145,350 containers of saline due to out of specification results, and in April it recalled almost 600,000 of saline units in VIAFLEX plastic containers because of missing closures and leaks.

At the end of June, Dr Reddy’s had to recall epilepsy drug divalproex sodium extended-release tablets, because they appeared to be too strong, and amlodipine besylate and atorvastatin calcium tablets (used to treat hypertension and angina), which weren’t strong enough.

Meanwhile, bilayer tablets of the obesity drug Contrave, manufactured by Orexigen and distributed by Takeda in the US, are causing further recall woes. The tablets are being recalled because they may break into the two drug components, though for now fewer than 4000 bottles are thought to be affected.

Actavis is having to recall 26 lots of its contraceptive pills Lutera after the packs were distributed with out-of-date package inserts. Around 511,283 boxes are affected, although FDA doesn’t think there is a danger to consumers.

And Mylan is recalling 14 lots of 10-mL prefilled syringes of calcium chloride intravenous infusions. The recall was first announced in April but Mylan has issued reminders since and is concerned that some affected lots may still be on the market. The problem is that administration could be difficult for the life-saving medicine because of incompatibility between the syringe and certain needleless adaptors. Earlier this year, Mylan had to recall several lots of injectable cancer drugs, many of which were manufactured for Pfizer, because of particulates.

While recalls seem to be coming thick and fast this month, the first quarter of 2015 was a quiet one for recalls of FDA-approved pharmaceuticals. According to Stericycle’s ‘Recall Scorecard’ for 2015’s first quarter, the early months of the year saw 44 pharmaceutical recalls, down by 40 percent compared with the previous quarter and the lowest level of recalls since 2012 (1). SteriCycle releases the scorecard every quarter. Interestingly, 16 percent of the first quarter’s recall activity was down to one unlucky company that had seven separate events. Who knows what the scorecard for the second quarter will show?

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  1. Stericycle Expert Solutions, Q1 2015 Recall Index, (May 2015).
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Stephanie Vine

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