0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Reported: July 27, 2016 Initiated: May 5, 2016 #D-1365-2016
Product Description
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
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
- 8,581 bags
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141. Recalled by Pharmedium Services, LLC. Units affected: 8,581 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-1365-2016.
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