Drug product

ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

D-0980-2016

May 17, 2016

Class II

Product summary

Firm: Well Care Compounding Pharmacy
Event: Event 74187
Status: Terminated
Classification: Class II
Quantity: 869 Units (All Products)
Official record key: drug-enforcement:D-0980-2016

Official wording

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

Code information: Lot #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp. 05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2016; Lot #:02112016:08 @13, Exp. 03/16/2016

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