0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
Reported: July 27, 2016 Initiated: May 5, 2016 #D-1370-2016
Product Description
0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
Reason for Recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Details
- Recalling Firm
- Pharmedium Services, LLC
- Units Affected
- 10 bags
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50. Recalled by Pharmedium Services, LLC. Units affected: 10 bags.
Why was this product recalled? ▼
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2016. Severity: Moderate. Recall number: D-1370-2016.
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