PharMEDium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate
PharMEDium Services is recalling 90 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of 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 involves a sterile injectable drug contaminated with glass particulate matter, which poses a significant risk of injury to patients.
Plain-English summary
PharMEDium Services, LLC is recalling 90 bags of 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is packaged in 200 mL in 250 mL Hospira LifeCare Bags and was compounded by PharMEDium Services in Memphis, Tennessee. The recall is being conducted because the active pharmaceutical ingredient (API) used to produce these sterile injectable drugs was contaminated with glass particulate matter.
The affected lots are 160730064M (Exp. 6/2/2016), 160800057M (Exp. 6/9/2016), 160820113M (Exp. 6/11/2016), and 160960142M (Exp. 6/26/2016). The product was distributed nationwide. This is a prescription-only medication.
Healthcare providers and patients should stop using the affected product and contact PharMEDium Services, LLC for further instructions or to arrange for the return of the product.
The recalled product
- Product
- 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 90
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 160730064M
- Exp. Date 6/2/2016
- Lot Number 160800057M
- Exp. Date 6/9/2016
- Lot Number 160820113M
- Exp. Date 6/11/2016
- Lot Number 160960142M
- Exp. Date 6/26/2016
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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