Recalls / Class I
Class ID-0658-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- Lot #:151370066M, Exp. 08/15/2015
Why it was recalled
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 19 Syringes
- Distribution pattern
- WI
Timeline
- Recall initiated
- 2015-05-22
- FDA classified
- 2016-02-10
- Posted by FDA
- 2016-02-17
- Terminated
- 2016-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0658-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.