PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 25 bags of compounded Sufentanil and Bupivacaine injectable solution because the active ingredient was 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, 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 25 bags of 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 100 ml Hospira LifeCare Bags. The recall is limited to Lot # 160970162M with an expiration date of 5/7/2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate. The presence of particulate matter in a sterile injectable product poses a risk to patients.
The affected product was distributed nationwide. Healthcare providers and patients who have received or possess this specific lot of the compounded medication should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 25
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 (2)
- Lot # 160970162M
- Exp. Date 5/7/2016
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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