Phenylephrine HCL 20 mg in 0 — Class II drug recall D-0903-2018
Terminated recall by SCA Pharmaceuticals, LLC, reported 2018-07-11, distributed nationwide. Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due
| Recall number | D-0903-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, LLC, Windsor, CT, United States |
| Recall initiated | 2018-06-14 |
| Classified | 2018-07-02 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2019-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 400 bags |
| Reason classes | sterility, packaging |
| Expiration dates | 2018-06-21 |
Product
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Reason for recall
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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-0903-2018. 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.