Montelukast 10 mg tablet, film coated

Where the pills inside were made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Camber Pharmaceuticals Inc. names for other drugs.

Repackaging site

• NuCare Pharmaceuticals,Inc., Orange, CA, United States · relabels it

Recalls

• Aug 20, 2018 · Class II · Hetero Labs Limited Unit V
  Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
  Lots: Lot #: MON17355, Exp 12/19
• Aug 15, 2018 · Class I · Hetero Labs Limited Unit V
  Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
  Lots: Lot #: MON17384, Exp 12/19
• Jan 7, 2017 · Class III · Hetero USA Inc
  Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
  Lots: Lot # MON16001B, Exp 01/18

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

Product details

Generic drug

Montelukast: every company that makes it

Form

tablet, film coated

Strength

10 mg

Approval

ANDA ANDA202843

On the market since

Sep 10, 2014

Package NDCs

68071-1561-3

Official label

DailyMed (National Library of Medicine), updated Jul 14, 2023

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?