Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Reported: March 10, 2021 Initiated: February 19, 2021 #D-0291-2021
Product Description
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Reason for Recall
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 10,440 90-count and 224,710 500-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 10,440 90-count and 224,710 500-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 10, 2021. Severity: Low. Recall number: D-0291-2021.
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