PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 15 bags of compounded morphine and bupivacaine injectable solution because the active ingredient was contaminated with 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 and involves a sterile injectable drug contaminated with glass particulates, which poses a significant risk of injury to patients.
Plain-English summary
PharMEDium Services, LLC is recalling 15 bags of 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag. The product is identified by Lot Number 160700041M and has an expiration date of 6/8/2016. The bags were distributed nationwide.
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 medications poses a risk to patient safety.
Healthcare facilities and patients who have received this specific lot of medication should contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the recalled product.
The recalled product
- Product
- 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 15
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: 160700041M
- Exp. Date 6/8/2016
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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