D-1853-2019 Class II Terminated
FDA drug recall D-1853-2019 was initiated by Compounded Solutions in Pharmacy on September 3, 2019 and is designated Class II. Reason for recall: Lack of Processing Controls: The recall status is terminated (terminated March 4, 2020). Affected quantity: 3x3 ml dropper bottles.
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
- 3x3 ml dropper bottles
Product Description
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
Reason for Recall
Lack of Processing Controls:
Distribution Pattern
Product was dispensed to patients
Code Information
Lots: 07172019@39 exp: 8/31/19, Rx # 215042 06192019@28 exp: 7/03/19, Rx # 219335 06052019@8 exp: 6/19/19; Rx # 222826