Kroger Recalls Lupron Depot Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling Lupron Depot 22.5 mg 3 month Kits due to a lack of processing controls. The recall affects lots dispensed in MS, LA, AR, IL, and FL between December 2017 and February 2018.
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 as a Class II recall, which typically indicates a moderate risk. However, the hazard is a 'lack of processing controls' for a drug product, which poses a potential risk of harm where injury has not yet been reported, aligning with the criteria for a High severity score.
Plain-English summary
Kroger Specialty Pharmacy, Inc. is voluntarily recalling Lupron Depot 22.5 mg 3 month Kits (NDC 00074-3346-03) because of a lack of processing controls. This defect could potentially affect the quality or safety of the drug product.
The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018. The affected products were distributed to patients in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Consumers who may have received this product should contact Kroger Specialty Pharmacy or their healthcare provider for instructions on what to do next. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
- Manufacturer
- Kroger Specialty Pharmacy, Inc.
- Category
- Drug — Hormone Therapy Injection
- 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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