Recalls / Class II
Class IID-1213-2018
Product
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.
- 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 #: MON17355, Exp 12/19
Why it was recalled
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
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
- 98,016 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-20
- FDA classified
- 2018-09-26
- Posted by FDA
- 2018-10-03
- Terminated
- 2021-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1213-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.