FDA Drug recall D-0951-2016
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per…
- 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, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per… 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-0951-2016 |
| 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, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Identifiers
| code_info | Lot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, 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-0951-2016%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.