Kroger Recalls Botox Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling Botox 100 Units Vials because of a lack of processing controls. The product was distributed in MS, LA, AR, IL, and FL.
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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for harm but no reported illness are scored as High (3). The hazard is theoretical based on processing controls.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is voluntarily recalling one lot of Botox 100 Units Vial (NDC 00023-1145-01) due to a lack of processing controls. This recall affects the 90-day supply product distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
The affected lots are those remaining within expiry that were dispensed between December 1, 2017, and February 12, 2018. Consumers who have this specific product should check their lot numbers and expiration dates against the recall information provided by the FDA.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class II. The agency defines Class II recalls as situations where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Botox 100 Units Vial
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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