Drug 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.
D-0658-2016
Product summary
- Event
- Event 72478
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19 Syringes
- Official record key
drug-enforcement:D-0658-2016
Official wording
Reason: Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Code information: Lot #:151370066M, Exp. 08/15/2015
Distribution pattern: WI
Derived failure modes
-
Potency or specification failure
subpotent