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D-0456-2016 Class II Terminated

Recalled by Western Drug — Springerville, AZ

FDA drug recall D-0456-2016 was initiated by Western Drug on October 19, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 1, 2016). Affected quantity: 2 containers.

Recall Details

Product Type: Drugs
Report Date: December 9, 2015
Initiation Date: October 19, 2015
Termination Date: October 1, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 containers

Product Description

Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

Code Information

all lots

Other recalls by Western Drug

D-0477-2016 Class II — Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, (October 19, 2015)
D-0411-2016 Class II — M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main (October 19, 2015)
D-0457-2016 Class II — Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/m (October 19, 2015)
D-0482-2016 Class II — Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springervill (October 19, 2015)
D-0458-2016 Class II — Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springervill (October 19, 2015)
D-0424-2016 Class II — Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, A (October 19, 2015)
D-0483-2016 Class II — Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Ar (October 19, 2015)
D-0452-2016 Class II — Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv (October 19, 2015)
D-0484-2016 Class II — Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Ari (October 19, 2015)
D-0433-2016 Class II — Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerv (October 19, 2015)