FDAFDA · Food and drugs·Recall number D-1213-2018
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Published October 3, 2018 · Recall initiated: August 20, 2018
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: A complaint was received from a pharmacist for the presence of blue specks on tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero Labs Limited Unit V
- Distributor
- Nationwide in the USA
- UPC
- 0331722726306
- Lot
- Lot #: MON17355, Exp 12/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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