Recalls / Class III
Class IIID-0623-2017
Product
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
- 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 # MON16001B, Exp 01/18
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.
Recalling firm
- Firm
- Hetero USA Inc
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1035 Centennial Ave, Piscataway, New Jersey 08854-4124
Distribution
- Quantity
- 65,664 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2017-01-07
- FDA classified
- 2017-03-29
- Posted by FDA
- 2017-04-05
- Terminated
- 2017-08-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0623-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.