FDAFDA · Food and drugs·Recall number D-0623-2017
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
Published April 5, 2017 · Recall initiated: January 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero USA Inc
- Distributor
- US Nationwide
- UPC
- 0331722726306
- Lot
- Lot # MON16001B, Exp 01/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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