Drug product

S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx

D-0250-2020

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: 11x10 ml glass vials
Official record key: drug-enforcement:D-0250-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: S03062019JL@11, Exp 9/6/19; S04282019DH@05, Exp 10/28/19; S06182019DT@04, Exp 12/18/19; S06242019DH@11, Exp 12/24/19; " S07232019DH@15, Exp 1/23/20

Distribution pattern: Nationwide in the USA

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility