NDC 55111-671
Clopidogrel bisulfate 300 mg tablet, film coated
On the label: Dr.Reddy's Laboratories Ltd..
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 |
| Dr. Reddy's Laboratories Limited | Srikakulam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 20, 2022 · 5 inspections |
Recalls
- Dec 10, 2018 · Class II · Dr. Reddy's Laboratories, Inc.
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Lots: Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020 - Nov 7, 2018 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Lots: Lot #: T600530, Exp 11/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clopidogrel: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 300 mg
- Approval
- ANDA ANDA091023
- On the market since
- May 17, 2012
- Package NDCs
55111-671-0155111-671-0555111-671-0655111-671-3055111-671-3155111-671-4855111-671-7855111-671-7955111-671-8155111-671-90- Official label
- DailyMed (National Library of Medicine), updated Dec 30, 2023
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