Recalls / Class I
Class ID-0081-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
- Brand name
- Montelukast Sodium
- Generic name
- Montelukast Sodium
- Active ingredient
- Montelukast Sodium
- Route
- Oral
- NDC
- 31722-726
- FDA application
- ANDA202843
- Affected lot / code info
- Lot #: MON17384, Exp 12/19
Why it was recalled
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Recalling firm
- Firm
- Hetero Labs Limited Unit V
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Unit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill., Jadcherla Mandal, Mahaboob Nagar, N/A, India
Distribution
- Quantity
- 98016 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-08-15
- FDA classified
- 2018-10-17
- Posted by FDA
- 2018-10-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0081-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.