Agency classClass IIOur severity:Severe FDA (Drugs)·D-1361-2016·Announced 2016-07-27

PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate

PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution 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, and the presence of glass particulate in a sterile injectable drug poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

PharMEDium Services, LLC is recalling 80 bags of 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bags. The product is a prescription-only sterile injectable drug compounded in Memphis, Tennessee, and was 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 affected lots include specific expiration dates ranging from May 2016 to July 2016.

Healthcare providers and patients should stop using the affected product immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product: 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
Manufacturer: Pharmedium Services, LLC
Category: Drug — Injectable
Hazard: glass-particulate
injection-injury
Affected units: 80

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 # 160420165M
Exp. 05/16 Lot # 160540128M
Exp. 05/16 Lot # 160630117M
Exp. 06/16 Lot # 160770157M
Exp. 06/16 Lot # 160870055M
Exp. 06/16 Lot # 160890153M
Exp. 06/16 Lot # 160950340M
Exp. 07/16

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.

See all 75 products in this recall →

Same manufacturer · Pharmedium Services, LLC

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Same hazard · glass particulate