Recalls / Class III
Class IIID-0888-2018
Product
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
- 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
- Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18
Why it was recalled
Failed Impurities/Degradation Specifications
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, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 130,081 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2018-06-12
- FDA classified
- 2018-06-21
- Posted by FDA
- 2018-06-27
- Terminated
- 2019-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0888-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.