Kroger Specialty Pharmacy Recalls Capecitabine Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they are reasonably likely to cause temporary or medically reversible adverse health consequences.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Capecitabine 500 mg tablets (NDC 00378-2512-78) in 28-day and 21-day supplies. The recall is being conducted due to a lack of processing controls.
The affected product consists of all lots remaining within their expiry dates that were dispensed between December 1, 2017, and February 12, 2018. The distribution pattern for these products includes Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have these specific lots of Capecitabine tablets should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. The FDA classifies this recall as Class II.
The recalled product
- Product
- Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Oncology
- 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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