Morphine Sulfate 0 — Class I drug recall D-0871-2016
Terminated recall by Pharmakon Pharmaceuticals, reported 2016-06-01, distributed in IL, IN. Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfa
| Recall number | D-0871-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmakon Pharmaceuticals, Noblesville, IN, United States |
| Recall initiated | 2016-02-11 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-05-16 |
| Distributed | IL, IN |
| Quantity | 75 syringes |
| Reason classes | potency, specification failure |
| NDC | 45183-0322-78 |
| Lot numbers | E52418EV11C |
| Expiration dates | 2016-03-19 |
Product
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Reason for recall
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
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-0871-2016. 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.