D-0418-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- January 29, 2018
- Termination Date
- December 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