Apotex Recalls Risperidone Oral Solution Due to Impurity Specification Failure
Apotex Inc. is recalling Risperidone Oral Solution because it failed impurity specifications at the 18-month stability time point.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Inc. is recalling Risperidone Oral Solution, 1 mg/mL, 30 mL bottles (NDC 60505-0380-1). The recall involves 11,422 bottles with Lot # KD4855 and an expiration date of 06/14. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because the product failed impurities/degradation specifications, specifically being out of specification for an impurity at the 18-month stability time point. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
- Manufacturer
- Apotex Inc.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 11,422
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 #: KD4855
- Exp 06/14
Distribution
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