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
Reported: April 5, 2017 Initiated: January 7, 2017 #D-0623-2017
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
Reason for Recall
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Details
- Recalling Firm
- Hetero USA Inc
- Units Affected
- 65,664 bottles
- Distribution
- US Nationwide
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero USA Inc. Units affected: 65,664 bottles.
Why was this product recalled? ▼
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Low. Recall number: D-0623-2017.
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