PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.
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 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products. The recall is being conducted because of a lack of sterility assurance.
The affected product is fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only. The specific NDC is 61553-303-28. The recall involves 1,350 units of the product.
The products were distributed nationwide in the US. Specific lot codes identified in the recall include 193520008D (Exp 3/18/2020) and 193540005D (Exp 3/22/2020). Consumers and healthcare providers should check their inventory against these lot numbers and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,350
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)
- 193520008D
- Exp 3/18/2020 193540005D
- Exp 3/22/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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 13 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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SeverePharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- HighPharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- ModeratePharmedium Recalls Fentanyl Citrate Injection Syringes Due to Stability Concerns
FDA (Drugs) · 2016-10-19
- ModerateFentanyl Citrate Injection Recalled Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- SeverePharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20