Recalls / Class III
Class IIID-0599-2021
Product
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
- 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
- Lot # C905063, Exp 07/2021
Why it was recalled
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
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
- 2980 500 count -bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-05-04
- FDA classified
- 2021-05-27
- Posted by FDA
- 2021-06-02
- Terminated
- 2023-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0599-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.