Kroger Specialty Pharmacy Recalls OPDIVO Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling OPDIVO 40 mg/4 mL SDV due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.
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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling OPDIVO 40 mg/4 mL SDV (NDC 00003-3772-11, 28 days supply) because of 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 source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the product.
Consumers who have this product should contact their healthcare provider or Kroger Specialty Pharmacy for instructions on how to proceed. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Oncology
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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