Hetero USA Recalls Montelukast Sodium Tablets Due to Discoloration
Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets, 10 mg, 30-count. The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. and distributed nationwide in the United States. The specific lot involved is # MON16001B with an expiration date of 01/18.
The recall was initiated after the firm received a complaint regarding a sealed bottle containing tablets with blue spots and blue powder inside the bottle. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Montelukast sodium tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The product is identified by NDC 31722-726-30.
The recalled product
- Product
- MONTELUKAST SODIUM (MONTELUKAST SODIUM)
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero USA Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 65,664
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # MON16001B
- Exp 01/18
UPCs (1)
- 0331722726306
Distribution
Distributed nationwide across the United States.
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