RecallRadar

FDA Drug recall D-0658-2016

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, Co…

On 2016-02-17 the FDA classified a Class I recall of 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, Co… by Pharmedium Services, citing sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0658-2016
ClassificationClass I
Statusterminated
Initiated2015-05-22
Published2016-02-17
Last updated2026-09-13 11:51 UTC
CompanyPharmedium Services
DistributionWI

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

Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Identifiers

code_infoLot #:151370066M, Exp. 08/15/2015

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-0658-2016%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.