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
Reported: October 3, 2018 Initiated: August 15, 2018 #D-0081-2019
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
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.
Details
- Recalling Firm
- Hetero Labs Limited Unit V
- Units Affected
- 98016 bottles
- Distribution
- U.S.A. Nationwide
- Location
- Jadcherla Mandal, Mahaboob Nagar
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero Labs Limited Unit V. Units affected: 98016 bottles.
Why was this product recalled? ▼
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2018. Severity: Critical. Recall number: D-0081-2019.
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