Re­call re­port: Miss­ing la­bel, mi­cro­bial con­t­a­m­i­na­tion leads to re­call of two batch­es of two drugs

My­lan Phar­ma­ceu­ti­cals has re­called a batch of Sem­glee in­sulin pens af­ter they were re­leased with­out la­bels, the FDA said.

A sin­gle batch of non-in­ter­change­able in­jec­tion, 100 units/ml, 3mL pack­aged in car­tons of five pens has been re­called. The batch — num­ber BF20003118 — ex­pires Aug. 2022.

The batch was made by Bio­con and dis­trib­uted by My­lan. A miss­ing la­bel could lead to a mixed-up dosage, and a pa­tient re­ceiv­ing treat­ment of more than one type of in­sulin, such as long- and short-act­ing in­sulin. That could lead to blood sug­ar lev­els too low or too high, and se­ri­ous com­pli­ca­tions.

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