Mallinckrodt Hospital Products Inc. is recalling 429 vials of Acthar Gel (repository corticotropin injection) and Terlivaz (terlipressin for injection) because of shipping delays that caused the products to be exposed to temperatures outside of their required storage range. The recall involves 8 vials of Acthar Gel and 421 vials of Terlivaz that were distributed to a specific distributor. These medications were sold throughout the United States.
Exposure to temperatures outside of the approved range (temperature excursion) can potentially affect the stability and potency of the medication. This may lead to the treatment being less effective than intended for patients.
Professional/Clinical return process
Recall #: D-0340-2024; 8 vials involved in recall.
Recall #: D-0341-2024; 421 vials involved in recall.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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