FDA-Drug2016-07-27Class II
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Pharmedium Services, LLC
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Sold states
Nationwide
Affected count
435 Monoject Syringes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1409-2016Don't want to check this manually?
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