Pharmedium Recalls Subpotent Morphine Sulfate Syringes in Wisconsin
Pharmedium Services, LLC is recalling 19 syringes of Morphine Sulfate in Wisconsin because the drug was found to be subpotent.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as subpotent drugs can lead to treatment failure.
Plain-English summary
Pharmedium Services, LLC is recalling 19 syringes of Morphine Sulfate, 2 mg per mL, in Sodium Chloride 0.9%. The product is a compounded drug intended for intravenous use only in hospital or office settings. The recall is limited to Lot #151370066M with an expiration date of 08/15/2015.
The recall was initiated because the firm's analysis revealed a subpotent result for the morphine sulfate assay. This means the medication did not contain the full amount of the active ingredient as labeled.
The affected product was distributed in Wisconsin. Healthcare facilities and offices that received this specific lot should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- 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.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #:151370066M
- Exp. 08/15/2015
Distribution
Distributed in 1 state:
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