Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Reported: June 23, 2021 Initiated: June 4, 2021 #D-0629-2021
Product Description
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Reason for Recall
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 5984 bottles
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 5984 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 23, 2021. Severity: Low. Recall number: D-0629-2021.
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