Reported Aug 22, 2018 · Terminated
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam -…
Dr. Reddy's Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only
- Mfd By
Dr. Reddy's Laboratories LimitedSrikakulam - 532 409 IndiaNDC 55111-123-05
- Lot codes and dates
- T60045
- Amount recalled
- 2280 bottles
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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