Drug product

S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx

D-0269-2020

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: 16 5ml and 10ml glass vials
Official record key: drug-enforcement:D-0269-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #:a) S06242019DH@07; 9/24/19 b) S07222019DH@09, Exp 10/22/19; S05292019DT@06, Exp 8/29/19; S06032019DT@08, Exp 9/3/19; S06242019DH@07; 9/24/19

Distribution pattern: Nationwide in the USA

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility