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.
FDA recall notice · announced February 17, 2016 · Pharmedium Services
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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 for recall
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Notes
Distribution: WI
Lot/code information: Lot #:151370066M, Exp. 08/15/2015
Quantity: 19 Syringes
Status: Terminated
Products in this recall event:
- 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/Of (D-0658-2016)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.