Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors
Pharmedium Services LLC is recalling morphine sulfate injection due to incorrect or missing lot and expiration dates on the labels.
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 recalling a specific lot of morphine sulfate in 0.9% sodium chloride injection. The product is a 2 mL vial containing 1 mg per mL, intended for intravenous use and compounded by Pharmedium Services LLC in Cleveland, Mississippi.
The recall was initiated because the product labels contain incorrect or missing lot and/or expiration dates. This labeling error could potentially affect the traceability and safety verification of the medication.
The affected product is identified by Lot 172360026C with an expiration date of 11/23/2017. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for this specific lot and contact the recalling firm for instructions.
The recalled product
- Product
- morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — 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 (2)
- Lot: 172360026C
- Exp. 11/23/2017
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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