Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors
Pharmedium Services LLC is recalling specific lots of compounded morphine sulfate injection because the labels may have incorrect or missing lot and expiration dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to documentation and labeling issues.
Plain-English summary
Pharmedium Services LLC is voluntarily recalling specific lots of morphine sulfate in 0.9% sodium chloride injection. The product is compounded for intravenous use and is available by prescription only. The recall is being conducted because the product labels may contain incorrect or missing lot numbers and/or expiration dates.
The affected products are identified by the following lot numbers and expiration dates: Lot 172410028C (Exp. 11/28/2017) and Lot 172470030C (Exp. 12/04/2017). The NDC number for the product is 61553-455-78. The source text indicates that the distribution pattern for these products was nationwide.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers and expiration dates. If the product is found, it should be held for return or disposal according to the recalling firm's instructions. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Hazard
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 (3)
- Lot:172410028C
- Exp. 11/28/2017 Lot: 172470030C
- Exp. 12/04/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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