Kroger Recalls Capecitabine Tablets Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling one lot of Capecitabine 150 mg tablets because the product lacks required processing controls. The recall affects units dispensed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
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 recall is classified as FDA Class II, which typically indicates products that might cause temporary health problems or pose slight threat of serious nature. The hazard 'Lack of Processing Controls' implies a risk of contamination or potency issues that could result in harm, fitting the 'risk-of-harm products where injury has not yet been reported' criterion for High severity.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is voluntarily recalling one lot of Capecitabine 150 mg Tablet (NDC 00378-2511-91) due to a lack of processing controls. The product is indicated for the treatment of certain cancers.
The recall includes all lots remaining within expiry that were dispensed from December 1, 2017, through February 12, 2018. Affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who have this product are advised to contact their pharmacy immediately for a replacement or refund. No adverse events or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Capecitabine Tablets
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.
See all 67 products in this recall →Related recalls
Same manufacturer · Kroger Specialty Pharmacy, Inc.
See all →- HighKroger Recalls Botox Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cimzia 200 mg/mL PFS Kits
FDA (Drugs) · 2018-05-16
- HighKroger Recalls Lupron Depot Due to Lack of Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Cyclophosphamide Capsules Due to Processing Controls
FDA (Drugs) · 2018-05-16
- ModerateKroger Specialty Pharmacy Recalls Sodium Chloride Inhalation Solution Due to Processing Controls
FDA (Drugs) · 2018-05-16
Same hazard · lack of processing controls
See all →- ModerateMasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls
FDA (Drugs) · 2020-08-05
- ModerateMasterPharm Recalls Yohimbine HCL Capsules Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
- ModerateMasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
- ModerateMasterPharm Recalls Calcium Citrate Powder Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
- ModerateMasterPharm Recalls Formula 82M Due to Lack of Processing Controls
FDA (Drugs) · 2020-08-05