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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: MON17384, Exp 12/19
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0081-2019
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 15, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 98016 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited Unit V
Original FDA data
Every field from FDA enforcement report D-0081-2019, exactly as published.
Show all FDA fields
- City
- Jadcherla Mandal, Mahaboob Nagar
- Status
- Ongoing
- Country
- India
- Event ID
- 80803
- Address
- Unit V (SEZ Unit I in APIIC SEZ)
- Address (line 2)
- Surv. No. 439-441, 458, Polepally Vill.
- Code information
- Lot #: MON17384, Exp 12/19
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-0081-2019
- Classification
- Class I
- Recalling firm
- Hetero Labs Limited Unit V
- Product quantity
- 98016 bottles
- Reason for recall
- Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Aug 15, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2018