PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 140 bags of compounded sufentanil and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
What this means for you
Illness, injury, or structural failure has been reported. 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 a sterile injectable drug represents a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 140 bags of 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 150 mL Baxter Intravia Bags. The product is compounded by PharMEDium Services in Memphis, Tennessee, and is available by prescription only. The specific lot number is 160970109M, with an expiration date of May 7, 2016.
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The presence of particulate matter in sterile injectable solutions poses a risk to patient safety.
The affected product was distributed nationwide. Healthcare providers and patients who have used or possess this specific lot of medication should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Solution
- Affected units
- 140
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 Number: 160970109M
- 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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