Recalls / Class III
Class IIID-1143-2015
Product
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
- Brand name
- Amlodipine Besylate And Atorvastatin Calcium
- Generic name
- Amlodipine Besylate And Atorvastatin Calcium
- Active ingredients
- Amlodipine Besylate, Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 43598-313, 43598-323, 43598-320, 43598-317, 43598-322, 43598-319, 43598-316, 43598-314, 43598-321, 43598-318 +1 more
- FDA application
- ANDA203874
- Affected lot / code info
- Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-06
- FDA classified
- 2015-06-18
- Posted by FDA
- 2015-06-24
- Terminated
- 2016-03-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1143-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.