FDA Recall D-0081-2019

Hetero Labs Limited Unit V

Class I — life-threatening Ongoing 2829 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot #: MON17384, Exp 12/19

Quantity: 98016 bottles

Reason for recall

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Recall record

Recall number: D-0081-2019
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2018-08-15
Classified by FDA Center: 2018-10-17
FDA published: 2018-10-03
Recalling firm: Hetero Labs Limited Unit V

Drug identification

Brand name(s): MONTELUKAST SODIUM
Generic name(s): MONTELUKAST SODIUM
Manufacturer(s): Camber Pharmaceuticals, Inc.
NDC(s): 31722-726
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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