NDC 43598-323
Amlodipine besylate and Atorvastatin calcium 10 mg / 2.5 mg tablet, film coated
On the label: Dr. Reddy's Laboratories Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Recalls
- Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: Lot #: C403575, Expiry: 10/2015 - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: Lot #: C403574, Expiry: 10/2015 - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: Lot #: C402341, Expiry: 08/2015 - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015. - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015 - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016 - Aug 13, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Subpotent atorvastatin.
Lots: Lot #: C404595, Expiry: 11/2015 - May 6, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent drug
Lots: Lot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015 - May 6, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent drug
Lots: Lot #: a) C401537, Exp 07/2015; b) C401539, Exp 07/2015 - May 6, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent drug
Lots: Lot # C309280 - May 6, 2015 · Class III · Dr. Reddy's Laboratories, Inc.
Subpotent drug
Lots: Lot # C402439
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amlodipine and Atorvastatin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg / 2.5 mg
- Approval
- ANDA ANDA203874
- On the market since
- Mar 17, 2014
- Package NDCs
43598-323-0543598-323-3043598-323-6043598-323-90- Official label
- DailyMed (National Library of Medicine), updated Feb 16, 2021
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