FDA Drug recall D-0623-2017
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETE…
- FDA Drug
- Class III
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class III recall of Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETE… by Hetero Usa, citing discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0623-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-01-07 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hetero Usa |
| Distribution | US |
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
Reason
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Identifiers
| ndc | 31722-726-30 |
|---|---|
| ndc | 31722-726-90 |
| ndc | 31722-726-01 |
| ndc | 31722-726-10 |
| ndc | 31722-726-31 |
| ndc | 31722-726-32 |
| code_info | Lot # MON16001B, Exp 01/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0623-2017%22
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