PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services, LLC is recalling 230 syringes of compounded Fentanyl Citrate and Bupivacaine HCl 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 a sterile injectable drug, which carries a significant risk of injury.
Plain-English summary
PharMEDium Services, LLC is recalling 230 BD syringes of 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free). The product is compounded in Memphis, Tennessee, and is available by prescription only. The recall covers six specific lots with expiration dates ranging from May 10, 2016, to June 22, 2016.
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 injection.
The affected product was distributed nationwide. Healthcare providers and patients who have received or possess these specific lots of the compounded medication should contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 230
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 (12)
- Lot Number 160410126M
- Exp. Date 5/10/2016
- Lot Number 160450114M
- Exp. Date 5/14/2016
- Lot Number 160460158M
- Exp. Date 5/15/2016
- Lot Number 160670040M
- Exp. Date 6/5/2016
- Lot Number 160730148M
- Exp. Date 6/12/2016
- Lot Number 160840112M
- Exp. Date 6/22/2016
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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