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.

FDA recall notice · announced October 3, 2018 · Hetero Labs Limited Unit V

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: MON17355, Exp 12/19
Quantity: 98,016 bottles
Status: Terminated
Products in this recall event:
- 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, (D-1213-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.