Could cause temporary or reversible harm; serious harm is unlikely.
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
| Brand name | INDOMETHACIN |
| Generic name | INDOMETHACIN |
| Active ingredient(s) | INDOMETHACIN |
| Distributed by / for | Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; |
| NDC | 31722-543-01 |
| Full product label | Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01. |
| Recalling firm | Hetero Labs, Ltd. - Unit III |
| Distribution | Nationwide in the USA |
| Quantity | 18,288 bottles |
| Recall initiated | 2018-07-18 |
| Report date | 2018-08-08 |
| Recall completed | 2021-07-15 |
| Recall number | D-1019-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Hyderabad N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗