FDA-Drug2018-07-11Class II

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

SCA Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Sold states
Product was distributed throughout the United States.
Affected count
2,869 bags
Manufactured in
755 Rainbow Rd Ste B, Windsor, CT, United States
Products
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0897-2018

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