Kroger Specialty Pharmacy Recalls Bethkis Ampules Due to Processing Control Issues
Kroger Specialty Pharmacy is recalling Bethkis 300 mg/4 mL ampules due to a lack of processing controls. The affected product was distributed in five states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Bethkis 300 mg/4 mL Ampule #56 (NDC 10122-0820-56), a 56-day supply. The recall was initiated because of a lack of processing controls.
The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall includes all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Injectable Medication
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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