Patients rely on drug labels to ensure they’re using their medications correctly. When those labels are MIA, recalls are sure to follow.
Such is the case with Viatris’ Mylan, which said Wednesday it was pulling one batch of non-interchangeable Semglee, also known as insulin glargine injection. The generics maker cited the risk of the label being missing on some prefilled pens contained inside labeled cartons of the drug.
The lot in question was produced by Biocon and distributed by Mylan in the U.S. between May 11, 2021, and Nov. 11, 2021, Viatris said in a notice posted to the FDA’s website. The batch, which contains cartons of five 3-ml prefilled Semglee pens, was due to expire in August 2022, according to the release.
Viatris did not say how many five-pen cartons were in the lot. The company did not immediately respond to Fierce Pharma’s request for comment.
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The labeling glitch could pose problems for patients who use both long- and short-acting insulin to manage their diabetes, Viatris warned. Patients could accidentally take the wrong insulin, which could hamper glycemic control, in turn leading to serious health risks.
As of Wednesday, Viatris had not received any safety reports linked to the recall.
The recall doesn’t cover Viatris’ recently launched interchangeable Semglee biosimilars, which come in branded and unbranded formats.
Viatris came to life in late 2020 as a result of the merger between Mylan and Pfizer’s Upjohn unit.
Packaging mix-ups are serious cause for concern, but a missing label isn’t the worst possible outcome.
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In an event the Institute for Safe Medication Practices called an “extremely hazardous packaging error,” generic drug maker Meitheal Pharmaceuticals last year recalled one lot of cisatracurium besylate, a muscle relaxant, after it received complaints that the cartons for that drug contained vials mislabeled as phenylephrine hydrochloride, which is used to treat low blood pressure.
Meitheal said at the time it hadn’t received any side effect reports linked to the recall, but a mix-up of the drugs could have been tragic.
