Kroger Recalls Sprycel Tablets Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling Sprycel 100 mg tablets because of a lack of processing controls. The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II due to a lack of processing controls, which poses a risk of harm where injury has not yet been reported. This aligns with the High severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is voluntarily recalling Sprycel 100 mg tablets (NDC 00003-0852-22) due to a lack of processing controls. The recall affects the 30-day supply product distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
The affected units are all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018. Consumers who have this specific medication should contact their pharmacy or healthcare provider for further instructions.
The recalled product
- Product
- Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug
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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