Drug product

METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-1002-2016

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-1002-2016

Official wording

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

Code information: Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016.

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