NDC 61919-258
Atorvastatin Calcium 20 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-122.
Where the pills inside were 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 |
| Dr. Reddy's Laboratories Limited | Srikakulam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 20, 2022 · 5 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jun 4, 2021 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Lots: Lot #: C905064, C905065, Exp. Date 07/2021 - May 4, 2021 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Lots: Lot # C905063, Exp 07/2021 - Feb 19, 2021 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Lots: a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 … - Aug 2, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Lots: T60045 - Jun 12, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot #: T600327, Exp 07/18; T700213, T700215, Exp 04/19 - Jun 12, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot #: T600328, Exp 07/18; T700214, T700216, Exp 04/19 - Jun 12, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: Lot #: a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18 - Jan 29, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Lots: Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018 - Jan 29, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Lots: Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018 - Jan 29, 2018 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Lots: Lot number: T600279, 6/2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atorvastatin: every company that makes it
- Form
- tablet
- Strength
- 20 mg
- Approval
- ANDA ANDA091650
- On the market since
- Jan 1, 2015
- Package NDCs
61919-258-3061919-258-90- Official label
- DailyMed (National Library of Medicine), updated Apr 17, 2023
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