Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam -…
- Recall date
- August 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1079-2018
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- U.S.A. 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.
Class III means the product violates regulations but is not likely to cause harm.
What 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
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