Kroger Specialty Pharmacy Recalls Xtandi Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Xtandi 40 mg capsules due to a lack of processing controls. The affected products were dispensed in five states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this recall as Class II. According to the severity rubric, an FDA Class II recall corresponds to a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Xtandi 40 mg capsules (NDC 00469-0125-99, 30-day supply) due to a lack of processing controls. The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.
The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Prescription Medication
- 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 (1)
- All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Distribution
Part of a larger recall action
This product is one of 67 recalled by Kroger Specialty Pharmacy, 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.
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