Hetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error
Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because one lot may contain Losartan Potassium 50 mg tablets.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Hetero Labs Limited Unit V is recalling 98,016 bottles of Montelukast Sodium Tablets 10 mg, 30-count, prescription-only. The product is manufactured in India for Camber Pharmaceuticals, Inc. The recall involves Lot # MON17384 with an expiration date of 12/19.
The recall was initiated due to a labeling mix-up. One lot labeled as Montelukast Sodium Tablets 10 mg may contain 90 tablets of Losartan Potassium 50 mg. This discrepancy means patients may receive a different medication than prescribed.
The affected product was distributed nationwide in the U.S.A. Consumers and healthcare providers should check their medication for the specific lot number and expiration date. If the medication matches the recalled lot, it should be returned to the pharmacy or contact the manufacturer for instructions.
The recalled product
- Product
- MONTELUKAST SODIUM (MONTELUKAST SODIUM)
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero Labs Limited Unit V
- Category
- Drug — Prescription Drug
- Affected units
- 98,016
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 #: MON17384
- Exp 12/19
UPCs (1)
- 0331722726306
Distribution
Distributed nationwide across the United States.
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