Class II
Terminated
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.
- Company
- Hetero Labs Limited Unit V
- Recall Initiated
- August 20, 2018
- Posted
- October 3, 2018
- Recall Number
- D-1213-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 98,016 bottles
- Firm Location
- Jadcherla Mandal, Mahaboob Nagar, India
Reason for Recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: MON17355, Exp 12/19
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