Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 3,927 syringes of compounded fentanyl and bupivacaine because glass particulates were found in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. 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 presence of glass particulates in sterile injectable drugs poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Pharmedium Services, LLC is recalling 3,927 syringes of 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The affected products are sterile injectable drugs compounded by Pharmedium Services, LLC in Memphis, TN, and were distributed nationwide.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The source text does not report any specific illnesses or injuries associated with this contamination.
Healthcare providers and patients should stop using the affected syringes and contact Pharmedium Services, LLC for further instructions or a replacement. The recall covers specific lot numbers and expiration dates ranging from May 2016 to July 2016, as detailed in the FDA recall notice D-1426-2016.
The recalled product
- Product
- 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 3,927
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 2H8139
- Lot Number 160420171M
- Exp. Date 5/12/2016
- Lot Number 160460111M
- Exp. Date 5/16/2016
- Lot Number 160490001M
- Exp. Date 5/18/2016
- Lot Number 160530289M
- Exp. Date 5/23/2016
- Lot Number 160560215M
- Exp. Date 5/26/2016
- Lot Number 160590055M
- Exp. Date 5/29/2016
- Lot Number 160600232M
- Exp. Date 5/30/2016
- Lot Number 160610189M
- Exp. Date 5/31/2016
- Lot Number 160670159M
- Exp. Date 6/6/2016
- Lot Number 160740151M
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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