Montelukast Sodium Tablet, Film Coated
FDA Recall NDC 31722-726
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Montelukast Sodium (NDC 31722-726). A significant event, classified as Class II, was initiated on Aug 20, 2018 by Camber Pharmaceuticals, Inc.. The reported reason for this action was: "Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Aug 20, 2018
Oct 03, 2018
98,016 bottles
Recall Profile & Regulatory Data
Event ID
81029
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 05, 2021
Product Description
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Batch or Lot Expiration Information
Lot# : MON17355, Exp 12/19
Affected Packages Involved in this Recall
31722-726-30Product
31722-726-90Product
31722-726-01Product
31722-726-10Product
31722-726-31Product
31722-726-32Product
Class I Ongoing
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Aug 15, 2018
Oct 03, 2018
98016 bottles
Recall Profile & Regulatory Data
Event ID
80803
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Hetero Labs Limited Unit V
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Batch or Lot Expiration Information
Lot# : MON17384, Exp 12/19
Affected Packages Involved in this Recall
31722-726-30Product
31722-726-90Product
31722-726-01Product
31722-726-10Product
31722-726-31Product
31722-726-32Product
Class III Terminated
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Jan 07, 2017
Apr 05, 2017
65,664 bottles
Recall Profile & Regulatory Data
Event ID
76412
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hetero USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Aug 08, 2017
Product Description
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Batch or Lot Expiration Information
Lot# MON16001B, Exp 01/18
Affected Packages Involved in this Recall
31722-726-30Product
31722-726-90Product
31722-726-01Product
31722-726-10Product
31722-726-31Product
31722-726-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
