D-0951-2016 Class III Terminated
FDA drug recall D-0951-2016 was initiated by Lupin Pharmaceuticals Inc. on Mar 11, 2016 and is designated Class III. Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. The recall status is terminated (terminated Aug 14, 2017). Affected quantity: 15408 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 8, 2016
- Initiation Date
- Mar 11, 2016
- Termination Date
- Aug 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15408 vials
Product Description
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 for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0951-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026