Morphine Sulfate — Class I drug recall D-0658-2016
Terminated recall by Pharmedium Services, LLC, reported 2016-02-17, distributed in WI. Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
| Recall number | D-0658-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2015-05-22 |
| Classified | 2016-02-10 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-02-18 |
| Distributed | WI |
| Quantity | 19 syringes |
| Reason classes | potency |
| NDC | 61553-0401-44 |
| Lot numbers | 151370066M |
| Expiration dates | 2015-08-15 |
Product
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.
Reason for recall
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
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-0658-2016. 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.