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Pharmedium Services, LLC recalls 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD S

Recalled July 27, 2016 · FDA recall D-1384-2016 · Pharmedium Services

Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. · FDA Class II
Units
1,577 BD syringes
Sold at
Nationwide

Description

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Product
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
Manufacturer(s)
Pharmedium Services, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Pharmedium Services, LLC recalls 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD S | RecallWatchUSA