Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.
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 sterile injectable drugs, which poses a significant risk of injury to patients.
Plain-English summary
Pharmedium Services, LLC is recalling 600 Monoject syringes of 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves specific lots of the 10 mL in 12 mL Monoject Syringe (Service Code 2T6014) and the 50 mL in 60 mL BD Syringe (Service Code 2T6636). The affected products were distributed nationwide.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable medications poses a risk to patients who receive the injections.
Healthcare providers and patients should check their inventory and records for the specific lot numbers and expiration dates listed in the recall notice. If any of these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Consumers should not use these products and should contact their healthcare provider if they have received an injection from one of the affected lots.
The recalled product
- Product
- 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium…
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 600
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 2T6014
- Lot Number 160390220M
- Exp. Date 5/9/2016
- Lot Number 160700029M
- Exp. Date 6/8/2016
- Service Code 2T6636
- Lot Number 160380145M
- Exp. Date 5/7/2016
- Lot Number 160390003M
- Exp. Date 5/8/2016
- Lot Number 160460177M
- Exp. Date 5/15/2016
- Lot Number 160490165M
- Exp. Date 5/18/2016
- Lot Number 160550201M
- Exp. Date 5/24/2016
- Lot Number 160670237M
- Exp. Date 6/6/2016
- Lot Number 160680008M
- Lot Number 160700023M
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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