RecallRadar

FDA Drug recall D-0095-2019

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 6…

On 2018-10-31 the FDA classified a Class II recall of Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 6… by Pfizer, citing lack of assurance of sterility: loss of container integrity.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0095-2019
ClassificationClass II
Statusterminated
Initiated2018-09-20
Published2018-10-31
Last updated2026-09-13 11:52 UTC
CompanyPfizer
DistributionUS

Product

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

Lack of assurance of sterility: loss of container integrity.

Identifiers

code_infoLot: 609G047, EXP 10/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0095-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.