Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Reported: July 17, 2013 Initiated: May 2, 2013 #D-686-2013
Product Description
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Reason for Recall
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 168,300 vals
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.. Recalled by Hospira Inc.. Units affected: 168,300 vals.
Why was this product recalled? ▼
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2013. Severity: Moderate. Recall number: D-686-2013.
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