Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Reported: June 11, 2014 Initiated: April 21, 2014 #D-1358-2014
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Reason for Recall
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 85,680 vials
- Distribution
- Nationwide.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.. Recalled by Hospira Inc.. Units affected: 85,680 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 11, 2014. Severity: Critical. Recall number: D-1358-2014.
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