Drug recall
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC…
FDA recall event 71375 · Class III · Dr. Reddy's Laboratories, Inc.
Key facts
| Event ID | 71375 |
|---|---|
| Recall numbers | D-1143-2015, D-1144-2015, D-1145-2015, D-1146-2015 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Product type | Drugs |
| Products | Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's…, Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90, 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…, Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent drug |
| Initiation date | May 6, 2015 |
| Report date | Jun 24, 2015 |
| Termination date | Mar 31, 2016 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003989912 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: