NDC 50436-1180

Tizanidine 4 mg tablet

On the label: Unit Dose Services. It's a repackaged product: Unit Dose Services rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-180.

Where the pills inside were made

Medchal-Malkajgiri, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection Oct 27, 2023. 8 inspections on record.

Srikakulam, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection May 20, 2022. 5 inspections on record.

Jan 2, 2024 · Class II · Completed
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Lots: Lot #: T2304007, Exp 7/31/2026
Jun 21, 2023 · Class II · Ongoing
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 · Terminated
Failed Tablet/Capsule Specification: Some tablets are shaved
Lots: Lot #: T2000471, exp date 09/2023
Sep 4, 2018 · Class II · Terminated
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 · Terminated
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.

Generic drug: Tizanidine: see every company that makes it
Form: tablet
Strength: 4 mg
Approval: ANDA ANDA076286
On the market since: Jul 3, 2002
Package NDCs: 50436-1180-1 50436-1180-2 50436-1180-3
Official label: DailyMed (National Library of Medicine), updated Oct 22, 2021

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