D-0736-2018 Class II Terminated
FDA drug recall D-0736-2018 was initiated by Kroger Specialty Pharmacy, Inc. on Apr 3, 2018 and is designated Class II. Reason for recall: Lack of Processing Controls. The recall status is terminated (terminated May 7, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- Apr 3, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Reason for Recall
Lack of Processing Controls.
Distribution Pattern
MS, LA, AR, IL, FL
Code Information
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0736-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026