ACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
Mallinckrodt is recalling ACTHAR Gel vials due to the presence of glass and stopper pieces. Patients should stop using the product and contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as particulate matter in an injectable drug) are categorized as Severe (Score 4).
Plain-English summary
Mallinckrodt Hospital Products Inc. is recalling 12,367 vials of ACTHAR (repository corticotropin) Gel, 5 mL multiple-dose vials, due to the presence of particulate matter, specifically glass and stopper pieces. The affected product is distributed nationwide in the United States.
The recall involves specific lots of ACTHAR Gel with NDC 63004-8710-1 and NDC 63004-8710-2. Both lots have an expiration date of January 31, 2027. The product is a prescription-only medication administered via intramuscular or subcutaneous injection.
Patients and healthcare providers should stop using the affected vials immediately. Individuals who have received injections from these vials should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- ACTHAR (REPOSITORY CORTICOTROPIN)
- Brand
- ACTHAR
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 12,367
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 (3)
- Lot#: NDC 63004-8710-1 - 1564-107
- exp 1/31/2027 NDC 63004-8710-2 - 1564-107H
- exp 1/31/2027
UPCs (1)
- 0363004871213
Distribution
Distributed nationwide across the United States.
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