PharMEDium Recalls Fentanyl Citrate Bags Due to Expired Diluent
PharMEDium Services is recalling 590 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 hazard involves a labeling/compounding error (expired diluent) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
PharMEDium Services, LLC is recalling 590 bags of Fentanyl Citrate (Preservative Free) 10 mcg per mL compounded in Sodium Chloride 0.9%. The product is distributed in 100 mL LifeCare Bags and is available nationwide.
The recall was initiated because the diluent used to compound the product had expired prior to the expiration date assigned to the compounded product. This is classified as a labeling issue not elsewhere classified.
The affected lots are 170850012C and 170850020C, with an expiration date of 06/25/17. 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) 10 mcg per mL (1,000 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 61553-112-52.
- Manufacturer
- PharMedium Services, Llc
- Category
- Drug — Compounded Injectable
- Affected units
- 590
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)
- Lots: 170850012C and 170850020C 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.
See all 2 products in this recall →Related recalls
Same manufacturer · PharMedium Services, Llc
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · expired ingredient
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHand sanitizer recalled for use of expired active ingredient
FDA (Drugs) · 2022-08-31
- ModerateKRS Global Biotechnology Recalls Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredient
FDA (Drugs) · 2018-01-17
- ModerateFDA Recalls Bi-Est Cream Due to Expired Ingredient Dates
FDA (Drugs) · 2018-01-17
Similar recalls
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate IV Bags Due to Particulate Matter
FDA (Drugs) · 2015-09-30
- ModeratePharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations
FDA (Drugs) · 2018-08-15
- SeverePharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- CriticalPharmedium Recalls Subpotent Fentanyl Citrate Syringes for IV Use
FDA (Drugs) · 2016-02-24
- SeverePharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide
FDA (Drugs) · 2016-10-19