D-1133-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 13, 2017
- Initiation Date
- June 23, 2017
- Termination Date
- January 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles
Product Description
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Reason for Recall
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Distribution Pattern
Nationwide
Code Information
05092017@2B, 11/5/2017