Why it was recalled
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: MON17355, Exp 12/19
Where it was sold
Nationwide in the USA
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-1213-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 20, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 98,016 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero Labs Limited Unit V
Original FDA data
Every field from FDA enforcement report D-1213-2018, exactly as published.
Show all FDA fields
- City
- Jadcherla Mandal, Mahaboob Nagar
- Status
- Terminated
- Country
- India
- Event ID
- 81029
- Address
- Unit V (SEZ Unit I in APIIC SEZ)
- Address (line 2)
- Surv. No. 439-441, 458, Polepally Vill.
- Code information
- Lot #: MON17355, Exp 12/19
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-1213-2018
- Classification
- Class II
- Recalling firm
- Hetero Labs Limited Unit V
- Product quantity
- 98,016 bottles
- Termination date
- Nov 5, 2021
- Reason for recall
- Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 26, 2018