D-0658-2016 Class I Terminated
FDA drug recall D-0658-2016 was initiated by Pharmedium Services, LLC on May 22, 2015 and is designated Class I. Reason for recall: Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. The recall status is terminated (terminated Feb 18, 2016). Affected quantity: 19 Syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 17, 2016
- Initiation Date
- May 22, 2015
- Termination Date
- Feb 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 Syringes
Product Description
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.
Distribution Pattern
WI
Code Information
Lot #:151370066M, Exp. 08/15/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0658-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026