Recalls / Class III
Class IIID-0886-2018
Product
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
- 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 #: T600327, Exp 07/18; T700213, T700215, Exp 04/19
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
- 55,126 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-0886-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.