Label Mix-up Prompts Recall

Accord Healthcare Inc. is pulling 100-count bottles of 12.5-mg hydrochlorothiazide tablets after a customer reported opening a sealed bottle that instead contained 25-mg spironolactone tablets, according to the September 19, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles labelled hydrochlorothiazide tablets USP, 12.5 mg (NDC 16729-182-01), from lot PW05264 (Exp. 11/19). The tablets were manufactured for Accord Healthcare by Intas Pharmaceuticals Limited. Some 46,632 bottles have been distributed in the United States and Puerto Rico.

Accord Healthcare voluntarily initiated the recall August 21, 2018. At the time of the enforcement report, the FDA had not yet issued a recall classification.

Both medications are prescription diuretics. According to an Accord Healthcare press release, use of spironolactone tablets instead of hydrochlorothiazide tablets poses a risk of hyperkalemia (increased potassium levels) in some patients, which could lead to life-threatening situations.

As of August 27, 2018, the date the press release was issued, Accord had not received any reports of adverse events related to the recall.

—Jolynn Tumolo

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