Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Reported: August 22, 2018 Initiated: August 2, 2018 #D-1079-2018
Product Description
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Reason for Recall
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 2280 bottles
- Distribution
- U.S.A. Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 2280 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 22, 2018. Severity: Low. Recall number: D-1079-2018.
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