Drug recall D-0081-2019

Class I Ongoing reported Oct 3, 2018

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

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.

Lots and codes

Lot #: MON17384, Exp 12/19

Recall details

Recalling firm
Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
Quantity
98016 bottles
Distribution
U.S.A. Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 15, 2018

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