The Recall Desk
SevereFDA (Drugs)·D-0333-2019·Announced 2018-12-26

Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes

Pharmedium Services, LLC is voluntarily recalling 295 syringes of a fentanyl and ropivacaine injection that were 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall with a significant hazard (sub-potent medication) corresponds to a severity score of 4 (Severe), as it falls under the criteria for significant injury/property-damage reports or high-risk scenarios not reaching Class I.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 295 units of Fentanyl Citrate 2 mcg per mL and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection. The product is packaged in 50 mL total volume in a 60 mL BD Syringe and is prescription only. The specific lot number is 183220013C with an expiration date of 12/19/2018.

The recall was initiated because the product was found to be sub-potent, meaning it did not contain the full amount of the active ingredient required by the label. 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 United States. The recall was initiated on December 5, 2018, and was terminated on October 2, 2020. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
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: 183220013C Exp. 12/19/2018

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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