NDC 68084-645
Tizanidine 4 mg tablet
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-180.
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
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Jan 2, 2024 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Lots: Lot #: T2304007, Exp 7/31/2026 - Jun 23, 2023 · Class II · Amerisource Health Services LLC
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Lots: Lot 1004835, Exp 7/31/2023 - Jun 21, 2023 · Class II · Dr Reddy's Laboratories Limited
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Lots: Lot: T2100585, T2100586, T2100587, Exp 12/2023 - Jul 19, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specification: Some tablets are shaved
Lots: Lot #: T2000471, exp date 09/2023 - Sep 4, 2018 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Lots: Lot #: T800304, Exp. 03/2021 - Mar 19, 2013 · Class III · Dr. Reddy'S Laboratories
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Lots: Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tizanidine: every company that makes it
- Form
- tablet, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA076286
- On the market since
- Oct 1, 2013
- Package NDCs
68084-645-0168084-645-1168084-645-65- Official label
- DailyMed (National Library of Medicine), updated May 22, 2025
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