NDC 53808-0960

Hydroxyzine Hydrochloride 50 mg tablet, film coated

On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from KVK-TECH, Inc.'s NDC 10702-012.

Where the pills inside were made

Repackaging site

• State of Florida DOH Central Pharmacy, Location not on file · repackages it

Recalls

• Dec 11, 2013 · Class II · KVK-Tech, Inc.
  Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
  Lots: lot #11434, exp. Nov-14
• Dec 11, 2013 · Class II · KVK-Tech, Inc.
  Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
  Lots: NDC: 10702-011-01: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp.May-14; lot #10790, exp. Jun-14; lot # 10791, exp. Jun-14: lot # 10792, exp. Aug-14; lot #10983, exp. Sep-14; lot #10984, exp.Sep-14; lot #10986, exp. Oct-14; lot # 11034, exp. Nov-14; lot #11035, exp. Dec-14; l…
• Dec 11, 2013 · Class II · KVK-Tech, Inc.
  Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
  Lots: NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb…

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Hydroxyzine: every company that makes it

Form

tablet, film coated

Strength

50 mg

Approval

ANDA ANDA040788

On the market since

Jan 1, 2014

Package NDCs

53808-0960-1

Official label

DailyMed (National Library of Medicine), updated Sep 30, 2014

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