D-0073-2019 Class II Terminated
FDA drug recall D-0073-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 11,016 cans.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,016 cans
Product Description
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
Reason for Recall
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 170591E, Exp. 11/17/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0073-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026