Recalls / Class III
Class IIID-0418-2018
Product
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, 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 numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018
Why it was recalled
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
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
- a) 34,125; b) 3,540 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-01-29
- FDA classified
- 2018-02-13
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0418-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.