Recalls / Class III
Class IIID-1376-2015
Product
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), 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
- a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015.
Why it was recalled
Subpotent Drug: Subpotent atorvastatin.
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, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- a) 14,640 and b) 624 Bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2015-08-13
- FDA classified
- 2015-08-27
- Posted by FDA
- 2015-09-02
- Terminated
- 2016-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1376-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.