CLASS I Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report
Morphine Sulfate, 2 mg per mL (60 mg per total volume recalled
Pharmedium Services is recalling Morphine Sulfate, 2 mg per mL (60 mg per total volume in a Monoject Barrel Syringes in, distributed in Wisconsin. The recall was initiated on 22 May 2015 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0658-2016
- FDA event ID
- 72478
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 May 2015
- FDA classified
- 10 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Undeclared Sulfites
- Drug class
- Pain Medication
Timeline
| 22 May 2015 | Recall initiated by company | |
| 10 Feb 2016 | Classified by FDA | +264 days |
| 17 Feb 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Product as listed by the FDA
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.
Where it was distributed
WI
Questions about this recall
Is Morphine Sulfate, 2 mg per mL (60 mg per total volume in a Monoject Barrel Syringes in recalled?
Yes. Pharmedium Services recalled Morphine Sulfate, 2 mg per mL (60 mg per total volume in a Monoject Barrel Syringes in on 22 May 2015. The recall is Class I and its status is Terminated. Recall number D-0658-2016.
Why was it recalled?
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Which lots are affected?
Lot #:151370066M, Exp. 08/15/2015
Where was it sold?
WI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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