D-0711-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2017
- Initiation Date
- April 18, 2017
- Termination Date
- August 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 mL total
Product Description
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Distribution Pattern
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017.