Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Reported: July 15, 2015 Initiated: April 23, 2015 #D-1216-2015
Product Description
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Reason for Recall
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 150,950 Vials
- Distribution
- U.S. Nationwide including Guam.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.. Recalled by Hospira Inc.. Units affected: 150,950 Vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2015. Severity: Critical. Recall number: D-1216-2015.
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