FDA Drug recall D-0303-2015
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only
- FDA Drug
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only by Hospira, citing defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0303-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-24 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
Reason
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Identifiers
| code_info | Lot #: 609E014, Exp 1/2016; 609E015, Exp 1J/2016; 609E016, Exp 1/2016; 609E017, Exp 1/2016; 609E018, Exp 1/2016; 609E0…Lot #: 609E014, Exp 1/2016; 609E015, Exp 1J/2016; 609E016, Exp 1/2016; 609E017, Exp 1/2016; 609E018, Exp 1/2016; 609E019, Exp 1/2016; 601E025, Exp 1/2016; 601E027, Exp 1/2016; 601E028A, Exp 1/2016; 601E028B, Exp 1/2016; 601E028C, Exp 1/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hospira
- Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest…
FDA Drug · Class I · 2017-05-31 · Hospira - Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to…
FDA Device · Class II · 2017-01-18 · Hospira - 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…
FDA Drug · Class III · 2016-12-14 · Hospira - Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093…
FDA Drug · Class II · 2016-11-30 · Hospira - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0303-2015%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.