ACETYLCYSTEINE OPTH 5% Solution — Class II drug recall D-0027-2023
Ongoing recall by Pharmacy Plus, Inc. dba Vital Care Compounder, reported 2022-11-09, distributed in AL, LA, MS, TN. Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cann
| Recall number | D-0027-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmacy Plus, Inc. dba Vital Care Compounder, Hattiesburg, MS, United States |
| Recall initiated | 2022-10-07 |
| Classified | 2022-11-02 |
| Reported by FDA | 2022-11-09 |
| Distributed | AL, LA, MS, TN |
| Quantity | 2 droptainers |
| Reason classes | sterility |
| Lot numbers | 66017, 66177 |
| Expiration dates | 2022-10-13, 2022-10-19 |
Product
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason for recall
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
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-0027-2023. 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.