FDA-Drug2016-07-27Class II

5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20

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
5 syringes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1431-2016

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