Kroger Specialty Pharmacy Recalls Prolia Syringes Due to Processing Controls
Kroger Specialty Pharmacy is recalling Prolia 60 mg/1 mL syringes due to a lack of processing controls. The affected units were dispensed 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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is described as a lack of processing controls without specific injury reports, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Prolia 60 mg/1 mL PF syringes (NDC 55513-0710-01) due to a lack of processing controls. The recall covers all lots remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018.
The affected product was distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have this product should stop using it and contact their healthcare provider or Kroger Specialty Pharmacy for further instructions.
The recalled product
- Product
- Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Injectable 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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