PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 45 cassettes of compounded fentanyl and bupivacaine 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 presence of glass particulates in sterile injectable drugs represents a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 45 medical cassettes of 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is compounded in 100 mL Smiths Medical Cassettes and is available by prescription only. The recall covers four specific lots with expiration dates ranging from May 10, 2016, to July 8, 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 infusion.
The affected products were distributed nationwide. Healthcare providers and patients should stop using the recalled cassettes immediately and contact PharMEDium Services or their local FDA office for further instructions on disposal or replacement.
The recalled product
- Product
- 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 45
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 (8)
- Lot Number 160500008M
- Exp. Date 5/10/2016
- Lot Number 160940038C
- Exp. Date 6/24/2016
- Lot Number 160970126M
- Exp. Date 6/27/2016
- Lot Number 161080140M
- Exp. Date 7/8/2016
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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