PharMEDium Recalls Fentanyl Citrate Due to Expired Diluent
PharMEDium Services is recalling 295 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling/compounding error involving an expired diluent without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
PharMEDium Services, LLC is recalling 295 bags of Fentanyl Citrate (Preservative Free) 20 mcg per mL compounded in Sodium Chloride 0.9%. The product is identified by NDC 61553-605-52, Lot 170850021C, and an expiration date of 06/25/17.
The recall was initiated because the diluent used to compound the product had expired prior to the expiration date assigned to the final compounded product. This is classified as a labeling issue not elsewhere classified.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the product and contact PharMEDium Services or their pharmacist for instructions on return or disposal.
The recalled product
- Product
- Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
- Manufacturer
- PharMedium Services, Llc
- Category
- Drug — Compounded Injectable
- Affected units
- 295
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 (1)
- Lot: 170850021C Exp. 06/25/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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