Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services is recalling 5,727 sterile injectable cassettes containing fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.
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, which corresponds to a Severe rating under the rubric. The hazard involves glass particulate in a sterile injectable drug, which carries a significant risk of injury.
Plain-English summary
Pharmedium Services, LLC is recalling 5,727 units of 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is packaged in 100 mL Yellow Smiths Medical Cassettes and is distributed nationwide. The recall involves multiple service codes and lot numbers, with expiration dates ranging from May 2016 to July 2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate. The presence of particulate matter in sterile injectable medications poses a risk to patient safety.
Healthcare facilities and patients who have received or possess these specific cassettes should stop using them and contact Pharmedium Services, LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service…
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 5,727
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 3V8708
- Lot Number 160410168M
- Exp. Date 5/11/2016
- Lot Number 160600286M
- Exp. Date 5/30/2016
- Lot Number 160810284M
- Exp. Date 6/20/2016
- Lot Number 160820091M
- Service Code 2H8285
- Lot Number 160470170M
- Exp. Date 5/13/2016
- Lot Number 160530182M
- Exp. Date 5/19/2016
- Lot Number 160600296M
- Exp. Date 5/26/2016
- Lot Number 160670185M
- Exp. Date 6/2/2016
- Lot Number 160740253M
- Exp. Date 6/9/2016
- Lot Number 160820206M
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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