D-0418-2018 Class III Terminated
FDA drug recall D-0418-2018 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 29, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability The recall status is terminated (terminated Dec 7, 2018). Affected quantity: a) 34,125; b) 3,540 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2018
- Initiation Date
- Jan 29, 2018
- Termination Date
- Dec 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 34,125; b) 3,540 bottles
Product Description
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Reason for Recall
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Distribution Pattern
Nationwide
Code Information
Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0418-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026