Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 1,527 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
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 the hazard involves particulate matter in a sterile injectable drug, which carries a significant risk of injury.
Plain-English summary
Pharmedium Services, LLC is recalling 1,527 bags of 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 150 mL Baxter Intravia Bags and is available by prescription only. The recall covers specific lots distributed nationwide, with expiration dates ranging from May 2016 to July 2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate. The presence of particulate matter in sterile injectable medications poses a risk to patients who receive the product.
Healthcare facilities and patients who have received these specific lots should contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the affected product and should return it to the pharmacy or healthcare facility where it was obtained.
The recalled product
- Product
- 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 1,527
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 (20)
- Service Code 2K9998
- Lot Number 160460135M
- Exp. Date 5/10/2016
- Lot Number 160530146M
- Exp. Date 5/17/2016
- Lot Number 160590137M
- Exp. Date 5/23/2016
- Lot Number 160660221M
- Exp. Date 5/30/2016
- Lot Number 160730163M
- Exp. Date 6/6/2016
- Lot Number 160870147M
- Exp. Date 6/20/2016
- Lot Number 160880265M
- Exp. Date 6/21/2016
- Lot Number 160940206M
- Exp. Date 6/27/2016
- Lot Number 161080210M
- Exp. Date 7/11/2016
- Service Code 2T8998
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 75 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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