Prescription injection drug recalled due to temperature excursion during shipment
Acthar Gel (repository corticotropin injection) is being recalled due to a temperature excursion during shipping from the manufacturer to distributor. Lot #1564-103 should not be dispensed to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall due to a temperature excursion affecting pharmaceutical stability. No illnesses or injuries have been reported, fitting the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Acthar Gel (repository corticotropin injection), manufactured by Mallinckrodt Hospital Products Inc., is being recalled due to a temperature excursion that occurred during shipment from the manufacturer to the distributor. The FDA classified this as a Class II recall, indicating a potential health hazard. The affected lot is #1564-103 with an expiration date of 9/30/2024.
Eight vials were directly involved in the recall out of 16,479 vials that were distributed nationwide. The temperature excursion resulted from a shipping delay and was identified as a cGMP deviation. Affected distributors have been notified.
Patients and healthcare providers in possession of Acthar from lot #1564-103 should not use the medication and should contact their healthcare provider if they have already received a dose from this lot or have concerns about their treatment.
The recalled product
- Product
- ACTHAR (REPOSITORY CORTICOTROPIN)
- Brand
- ACTHAR
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Category
- Drug — Injectable hormone
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1564-103
- Exp 9/30/2024
UPCs (1)
- 0363004871213
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mallinckrodt Hospital Products Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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