PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services is recalling specific lots of compounded fentanyl and bupivacaine infusions because they were produced using an active pharmaceutical ingredient 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 involves a structural defect (glass particulates) in a sterile injectable drug, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
PharMEDium Services, LLC is recalling 40 medical cassettes of 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The recall involves six specific lots with expiration dates ranging from May 23, 2016, to June 18, 2016. The 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 patient safety.
Healthcare providers and facilities that have received these specific lots should stop using the product immediately. Consumers and patients should contact their healthcare provider if they have received an infusion from these lots to discuss any potential concerns or necessary medical follow-up.
The recalled product
- Product
- 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 40
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 160630037M
- Exp. Date 5/23/2016
- Lot Number 160640007M
- Exp. Date 5/24/2016
- Lot Number 160700207M
- Exp. Date 5/31/2016
- Lot Number 160730149M
- Exp. Date 6/3/2016
- Lot Number 160830163M
- Exp. Date 6/12/2016
- Lot Number 160880258M
- Exp. Date 6/18/2016
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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