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
Reported: February 7, 2018 Initiated: January 29, 2018 #D-0419-2018
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
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- a) 28,941 and b) 2,928 bottles
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: a) 28,941 and b) 2,928 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Low. Recall number: D-0419-2018.
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