FDA Drug recall D-1295-2014
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA B…
- FDA Drug
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA B… by Teva Pharmaceuticals Usa, citing CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1295-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-24 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Identifiers
| code_info | TE38139, Exp. 08/16, TE39022, Exp. 09/16, |
|---|
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-1295-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.