NDC 52959-689

Tizanidine 4 mg tablet

On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-180.

Where the pills inside were made

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 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

Strength

4 mg

Approval

ANDA ANDA076286

On the market since

Jul 3, 2002

Package NDCs

52959-689-02 52959-689-05 52959-689-08 52959-689-15 52959-689-20 52959-689-21 52959-689-30 52959-689-42 52959-689-45 52959-689-60 52959-689-63 52959-689-90

Official label

DailyMed (National Library of Medicine), updated Dec 21, 2011

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