D-0095-2019 Class II Terminated
FDA drug recall D-0095-2019 was initiated by Pfizer Inc. on Sep 20, 2018 and is designated Class II. Reason for recall: Lack of assurance of sterility: loss of container integrity. The recall status is terminated (terminated Sep 17, 2022). Affected quantity: 71,075 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2018
- Initiation Date
- Sep 20, 2018
- Termination Date
- Sep 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71,075 vials
Product Description
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Reason for Recall
Lack of assurance of sterility: loss of container integrity.
Distribution Pattern
Nationwide in the US and Puerto Rico
Code Information
Lot: 609G047, EXP 10/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0095-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026