PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services is recalling 30 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of 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. The hazard involves glass particulate matter in a sterile injectable drug, which poses a significant risk of injury (such as tissue damage or embolism) upon administration, meeting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 30 bags of 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. The product is a sterile injectable drug compounded in 250 mL Hospira LifeCare Bags. The recall involves two specific lots: Lot # 160890042M (Exp. Date 5/13/2016) and Lot # 160960052M (Exp. Date 5/20/2016).
The recall was initiated because the active pharmaceutical ingredient (API) used to produce the sterile injectable drugs was contaminated with glass particulate matter. The source text does not specify the number of affected units beyond the 30 bags mentioned in the product quantity, nor does it report any specific illnesses or injuries associated with the use of these products.
The affected products were distributed nationwide. Healthcare providers and patients who have received or used these specific lots of the compounded injectable drug should contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Sterile Injectable
- Affected units
- 30
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 (3)
- Lot # 160890042M
- Exp. Date 5/13/2016 Lot # 160960052M
- Exp. Date 5/20/2016
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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