FDA-Drug2018-08-22Class II

Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory
Hazard

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Sold states
Product was distributed within the state of Pennsylvania.
Affected count
5 droptainers
Manufactured in
1107 Lowry Ave, Jeannette, PA, United States
Products
Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1080-2018

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