Kroger Specialty Pharmacy Recalls Bendeka Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling Bendeka 25 mg/mL 4 mL MDVPF 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
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or property damage, or those not explicitly stated as having no reported illness, are scored as Severe (4).
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Bendeka 25 mg/mL 4 mL MDVPF (NDC 63459-0348-04, 28 days supply) 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 source text does not specify the exact quantity of units recalled or report any specific illnesses or injuries associated with the product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Pharmacy Compounded
- 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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