Why it was recalled
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Product description
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Lot numbers, UPCs & expiration codes
Lot # MON16001B, Exp 01/18
Where it was sold
US 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-0623-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 7, 2017
- FDA report date
- Apr 5, 2017
- Quantity
- 65,664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hetero USA Inc
Original FDA data
Every field from FDA enforcement report D-0623-2017, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76412
- Address
- 1035 Centennial Ave
- Code information
- Lot # MON16001B, Exp 01/18
- Postal code
- 08854-4124
- Report date
- Apr 5, 2017
- Product type
- Drugs
- Recall number
- D-0623-2017
- Classification
- Class III
- Recalling firm
- Hetero USA Inc
- Product quantity
- 65,664 bottles
- Termination date
- Aug 8, 2017
- Reason for recall
- Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jan 7, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 29, 2017