The Recall Desk
SevereFDA (Drugs)·D-0334-2019·Announced 2018-12-26

Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags

Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate and Ropivacaine HCl injection because the product was found to be sub-potent.

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. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II with potential for adverse health consequences (sub-potent medication) aligns with the 'Severe' criteria for significant risk or structural defects, and the rubric specifies Class II with hospitalization reports as Severe. While no hospitalizations are explicitly reported, the 'Sub-potent' nature of a potent opioid and anesthetic carries a high risk of treatment failure or adverse outcomes, justifying a score of 4 to reflect the serious nature of the defect in a critical medication.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection. The product is packaged in 100 mL total volume in 150 mL Intravia Bags and is marked as Rx Only. The specific lot number is 183230004C with an expiration date of 02/17/2019.

The recall was initiated because the product was found to be sub-potent, meaning it contained less of the active ingredient than labeled. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the USA. The recall was initiated on December 5, 2018, and the firm notified customers by telephone. The recall status is currently terminated as of October 2, 2020. Consumers and healthcare providers should check their inventory for this specific lot and expiration date and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
Hazard

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 (1)

  • Lot: 183230004C Exp. 02/17/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Pharmedium Services, LLC

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Same hazard · sub potent

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