CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report

0.15% Bupivacaine HCl (Preservative Free) recalled

Pharmedium Services is recalling 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride in Yellow Smiths, distributed nationwide in the US. The recall was initiated on 5 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ;

Quantity recalled315 Medical Cassettes

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-1366-2016
FDA event ID: 74057
Recalling firm: Pharmedium Services, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2016
FDA classified: 16 Jul 2016
Reported: 27 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

5 May 2016	Recall initiated by company
16 Jul 2016	Classified by FDA	+72 days
27 Jul 2016	Published in enforcement report	+11 days

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

Reason for recall

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Product as listed by the FDA

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Which lots are affected?

Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 160960019C , Exp. Date 7/5/2016 ;

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

74 other products · FDA event 74057

This product is part of a recall event; the main page for the event is 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl recalled.

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.2% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.1% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.0625% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.5% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.03% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016	CLASS II	0.125% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	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 Bupivacaine (preservative Free recalls

All 9

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016Drug	CLASS II	0.125% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.03% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.5% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.0625% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide