PharMEDium Recalls Morphine Sulfate IV Bags Due to Particulate Matter
PharMEDium Services is recalling 100 bags of Morphine Sulfate IV solution because the sodium chloride used contained human hair.
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 classified this as an FDA Class I recall, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
PharMEDium Services, LLC is recalling 100 bags of Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only. The product is identified by NDC# 61553-181-50. The recall is due to the presence of particulate matter, specifically human hair, in the Hospira 0.9% Sodium Chloride, USP injection used to manufacture the product.
The affected lots are 14308162M (Exp 02/02/15), 143130049M (Exp 02/08/15), 143220039M (Exp 02/16/15), 143490058M (Exp 03/16/15), and 143560029M (Exp 03/23/15). The products were distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC for further instructions.
The recalled product
- Product
- Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — IV Solution
- Affected units
- 100
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 (10)
- Lot #: 14308162M
- Exp 02/02/15
- 143130049M
- Exp 02/08/15
- 143220039M
- Exp 02/16/15
- 143490058M
- Exp 03/16/15
- 143560029M
- Exp 03/23/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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