D-0419-2018 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) 28,941 and b) 2,928 bottles
Product Description
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
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) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018