Janssen Recalls Risperdal CONSTA Due to Sterility Failure
Janssen Pharmaceuticals is recalling one lot of Risperdal CONSTA (risperidone) 25 mg dose packs due to a sterility failure detected in a stability sample.
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, and the hazard involves a sterility failure in a medication, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Janssen Pharmaceuticals, Inc. is recalling one lot of Risperdal CONSTA (risperidone) 25 mg Dose Packs. The recall is being conducted due to a sterility failure identified in a stability sample. The affected product is identified by Vial code 4212AAP1, Kit code 309316, and an expiration date of 07/15.
The recall involves 70,495 kits that were distributed nationwide. The product is a prescription-only, single-use medication manufactured by Janssen Pharmaceuticals, Inc. in Titusville, NJ.
Healthcare providers and patients should stop using the affected lots and contact Janssen Pharmaceuticals for further instructions or replacement products.
The recalled product
- Product
- RISPERDAL CONSTA (RISPERIDONE)
- Brand
- RISPERDAL CONSTA
- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Category
- Drug — Antipsychotic
- Affected units
- 70,495
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)
- Vial - 4212AAP1
- Kit - 309316
- Exp. 07/15
Distribution
Distributed nationwide across the United States.
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