Labeling Mix-Ups Prompt Recalls from Drugmakers

Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel.

Sagent initiated a recall of three lots of the painkiller ketorolac tromethamine injection single-dose vials because the expiration date on the label was longer than the known stability of the lots, which were made by India-based manufacturer Cadila Healthcare. Sagent didn’t elaborate on the extent of the labeling date discrepancy.

Meanwhile, Baxter Healthcare recalled a lot of potassium chloride injection due to a labeling error on the shipping carton that was caught by customers. The shipping carton for the lot may actually contain vials of gentamicine sulfate injection instead, Baxter said recently.

Potassium chloride is a treatment for potassium deficiency, while gentamicine sulfate is an antibiotic.  Since both products are packaged in 100 ml containers and have similar code numbers and red labeling on the front panel, there is “a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride,” Baxter said.

Both companies stressed that there have been no adverse events linked to the affected lots.

Drugmakers tend to not give labeling enough attention due to more pressing supply chain issues, James Robinson, a manufacturing consultant with xCell Strategic Consulting, said.

He recalled one manufacturer who failed to update a packaging insert on one of its websites for six months. The problem was the labeling insert was updated on the website advertising the product but not on company’s main website. The company failed to institute a second check to make sure someone saw the updated insert on the main website.

A second check by quality personnel to ensure that labeling is in fact correct or updated is the best way for drugmakers to prevent any snafus, Robinson said. “It really isn’t that complicated. It is just putting an extra step in,” he said.

Robinson also noted that the FDA appears to be cracking down on labeling problems since they could lead to medication errors if an incorrectly labeled product is administered to a patient.

Sagent said it was looking into the issue. Baxter did not respond to a request for additional comment as of press time.

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