CVS Health — Class II drug recall D-0073-2019
Terminated recall by Product Quest Manufacturing LLC, reported 2018-10-24, distributed nationwide. Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
| Recall number | D-0073-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Product Quest Manufacturing LLC, Daytona Beach, FL, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-16 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 11,016 cans |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00050428295250 |
| Lot numbers | 170591E |
| Expiration dates | 2018-11-17 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0073-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.