D-1854-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2019
- Initiation Date
- September 3, 2019
- Termination Date
- March 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 6x5ml b) 4x10 c) 1x15 ml bottles,
Product Description
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Reason for Recall
Lack of Processing Controls:
Distribution Pattern
Product was dispensed to patients
Code Information
Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19