Recalls / Class III
Class IIID-0726-2022
Product
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDC
- 55111-124
- FDA application
- ANDA202357
- Affected lot / code info
- Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
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
- 28,068 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-03-16
- FDA classified
- 2022-03-29
- Posted by FDA
- 2022-04-06
- Terminated
- 2023-11-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0726-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.