FDA Drug recall D-0954-2016
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manu…
- FDA Drug
- Class III
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class III recall of Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manu… by Lupin Pharmaceuticals, citing CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0954-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-11 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Identifiers
| code_info | Lot #: C500037, 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-0954-2016%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.