Recall Enforment Report D-0955-2016
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 03-11-2016 for the product Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India. The product was recalled due to cgmp deviations: active pharmaceutical ingredient intermediates failed specifications.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0955-2016 | 03-11-2016 | 06-08-2016 | Class III | 741.171 kg | Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India. | CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. | Terminated |
| D-0952-2016 | 03-11-2016 | 06-08-2016 | Class III | 7908 vials | Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
| D-0951-2016 | 03-11-2016 | 06-08-2016 | Class III | 15408 vials | 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. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
| D-0954-2016 | 03-11-2016 | 06-08-2016 | Class III | 570 vials | 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. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
| D-0953-2016 | 03-11-2016 | 06-08-2016 | Class III | 30586 vials | Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), 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. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. | Terminated |
