Recalls / Class III
Class IIID-1079-2018
Product
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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 55111-121, 55111-122, 55111-123
- FDA application
- ANDA091650
- Affected lot / code info
- T60045
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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 2280 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-08-02
- FDA classified
- 2018-08-14
- Posted by FDA
- 2018-08-22
- Terminated
- 2020-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1079-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.