FDA Drug recall D-1378-2015
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottl…
- FDA Drug
- Class III
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class III recall of Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottl… by Dr Reddy S Laboratories, citing subpotent Drug: Subpotent atorvastatin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1378-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-13 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Reason
Subpotent Drug: Subpotent atorvastatin.
Identifiers
| ndc | 43598-323-30 |
|---|---|
| ndc | 43598-323-60 |
| ndc | 43598-323-90 |
| ndc | 43598-323-05 |
| ndc | 43598-320-30 |
| ndc | 43598-320-60 |
| ndc | 43598-320-90 |
| ndc | 43598-320-05 |
| ndc | 43598-317-30 |
| ndc | 43598-317-60 |
| ndc | 43598-317-90 |
| ndc | 43598-317-05 |
| ndc | 43598-322-30 |
| ndc | 43598-322-60 |
| ndc | 43598-322-90 |
| ndc | 43598-322-05 |
| ndc | 43598-319-30 |
| ndc | 43598-319-60 |
| ndc | 43598-319-90 |
| ndc | 43598-319-05 |
| ndc | 43598-316-30 |
| ndc | 43598-316-60 |
| ndc | 43598-316-90 |
| ndc | 43598-316-05 |
| ndc | 43598-314-30 |
| ndc | 43598-314-60 |
| ndc | 43598-314-90 |
| ndc | 43598-314-05 |
| ndc | 43598-321-30 |
| ndc | 43598-321-60 |
| ndc | 43598-321-90 |
| ndc | 43598-321-05 |
| ndc | 43598-318-30 |
| ndc | 43598-318-60 |
| ndc | 43598-318-90 |
| ndc | 43598-318-05 |
| ndc | 43598-315-30 |
| ndc | 43598-315-60 |
| ndc | 43598-315-90 |
| ndc | 43598-315-05 |
| ndc | 43598-313-30 |
| ndc | 43598-313-60 |
| ndc | 43598-313-90 |
| ndc | 43598-313-05 |
| code_info | a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1378-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.