D-0356-2019 Class I Terminated
FDA drug recall D-0356-2019 was initiated by Lupin Pharmaceuticals Inc. on Dec 20, 2018 and is designated Class I. Reason for recall: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. The recall status is terminated (terminated Aug 18, 2020). Affected quantity: a) 8,000 vials; b) 32,045 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 16, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Aug 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 8,000 vials; b) 32,045 boxes
Product Description
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use 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.
Reason for Recall
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: a) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0356-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026