Kroger Specialty Pharmacy Recalls Azithromycin Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the Class II classification for a drug with a processing control failure aligns with the Severe criteria in the absence of Class I indicators.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is recalling Azithromycin 250 mg tablets (NDC 50111-0787-66) due to a lack of processing controls. The recall involves a 28-day supply of the medication.
The affected lots are those remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018. The products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for further instructions. 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
- Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Antibiotic
- 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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