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Antibiotic Recalled

Sandoz Inc. has issued a voluntary recall for 23,053 bottles of 100-mg nitrofurantoin capsules, USP (monohydrate/macrocrystals) manufactured for Northstar Rx. The recall was prompted by cross-contamination of the capsules with other products, according to the November 21, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles (NDC 16714-439-01) from lots JA7319, JA 7320, and JA7321, which have a March 2020 expiration date. The capsules were distributed throughout the United States.

Sandoz voluntarily initiated the recall November 2, 2018. On November 20, 2018, the FDA designated it Class III, signaling use of capsules affected by the recall is unlikely to cause adverse health consequences.

Nitrofurantoin is a prescription antibiotic used to treat urinary tract infections caused by certain bacteria.

Jolynn Tumolo


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