FDA Drug recall D-0871-2016
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, syrin…
- FDA Drug
- Class I
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class I recall of 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, syrin… by Pharmakon Pharmaceuticals, citing super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0871-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-11 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmakon Pharmaceuticals |
| Distribution | IL, IN |
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
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Identifiers
| code_info | Lot #: E52418EV11C, Exp 03/19/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0871-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.