Drug product

HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0990-2016

May 17, 2016

Class II

Product summary

Firm: Well Care Compounding Pharmacy
Event: Event 74187
Status: Terminated
Classification: Class II
Quantity: 869 Units (Total All Products)
Official record key: drug-enforcement:D-0990-2016

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Code information: Lot #: 03012016:82@33, Exp. 05/30/2016; Lot #: 03012016:65@41, Exp. 06/16/2016; Lot #: 04142016:89@48, Exp. 07/12/2016; Lot #: 04142016: 28@49, Exp. 07/17/2016

Distribution pattern: NV

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

GMP violations
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility