Drug product

HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10

D-0156-2019

September 10, 2018

Class II

Product summary

Firm: Pharm D Solutions, LLC
Event: Event 81002
Status: Terminated
Classification: Class II
Quantity: 2219 vials
Official record key: drug-enforcement:D-0156-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04252018:33 Discard by: 10/21/2018; 05082018:39 Discard by: 11/4/2018; 06262018:00 Discard by: 12/23/2018; 07192018:13 Discard by: 1/15/2019; 08012018:46 Discard by: 1/28/2019; 08212018:69 Discard by: 11/30/2018

Distribution pattern: Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility