FDAFebruary 6, 2024drug

Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

What to do

FDA enforcement status: Ongoing

Brands named

mallinckrodt hospital productsmallinckrodtmallinckrodt hospital

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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