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Recall Observatory FDA recall evidence

Drug product

S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

D-0207-2020

August 12, 2019

Class II

Product summary

Firm
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Event
Event 83669
Status
Terminated
Classification
Class II
Quantity
18x10 ml and 1x5 ml glass vials
Official record key
drug-enforcement:D-0207-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility