D-0003-2020 Class II Terminated
FDA drug recall D-0003-2020 was initiated by Colonia Care Pharmacy on Jul 24, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: product sterility cannot be guaranteed. The recall status is terminated (terminated Apr 5, 2023). Affected quantity: 2 droptainer bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 9, 2019
- Initiation Date
- Jul 24, 2019
- Termination Date
- Apr 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 droptainer bottles
Product Description
C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason for Recall
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Distribution Pattern
Patient Specific Prescriptions in NJ
Code Information
Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0003-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026