NDC 63739-037
Atorvastatin Calcium 80 mg tablet
On the label: McKesson Packaging Services Business Unit of McKesson Corporation. It's repackaged: McKesson Packaging Services Business Unit of McKesson Corporation rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-124.
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 |
Recalls
- Mar 16, 2022 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Lots: Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023 - May 30, 2018 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Lots: Lot #: T800064, Exp 12/2019
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
- 80 mg
- Approval
- ANDA ANDA202357
- On the market since
- Jul 17, 2012
- Package NDCs
63739-037-33- Official label
- DailyMed (National Library of Medicine), updated Nov 12, 2021
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