D-0953-2016 Class III Terminated
FDA drug recall D-0953-2016 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: 30586 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
- 30586 vials
Product Description
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.
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 #: C400180, Exp 07/17; C500003, C500028, C500029, Exp 122/17; C500038, Exp 01/18; C500044, Exp 02/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0953-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026