CLASS III Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report

Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled

Pharmedium Services is recalling Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection, distributed nationwide in the US. The recall was initiated on 15 Feb 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: 170170204s; Exp. 01/01/1900

Quantity recalled10 I.V. pumps

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0933-2017
FDA event ID: 77374
Recalling firm: Pharmedium Services, Lake Forest, IL
Classification: Class III
Status: Terminated
Recall initiated: 15 Feb 2017
FDA classified: 2 Jul 2017
Reported: 12 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Drug class: Injectable & IV Drugs

Timeline

15 Feb 2017	Recall initiated by company
2 Jul 2017	Classified by FDA	+137 days
12 Jul 2017	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Product as listed by the FDA

Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date

Which lots are affected?

Lot: 170170204s; Exp. 01/01/1900

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 77374

This product is part of a recall event; the main page for the event is Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled.

Reported	Class	Recall	Company	Reason	Where
12 Jul 2017	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017	CLASS III	Bupivacaine HCl 0.25% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017	CLASS III	Bupivacaine HCl 0.25% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017	CLASS III	Ropivacaine HCl 0.2% Total Volume in an AutoFuser Pump recalled	Pharmedium Services	Other	Nationwide

More recalls from Pharmedium Services

All 291

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide

Other Ropivacaine Total Volume recalls

All 5

Reported	Class	Recall	Company	Reason	Where
12 Jul 2017Drug	CLASS III	Ropivacaine HCl 0.2% Total Volume in an AutoFuser Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017Drug	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017Drug	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide
12 Jul 2017Drug	CLASS III	Ropivacaine HCl 0.2% Total Volume in an ON-Q Pump recalled	Pharmedium Services	Other	Nationwide