CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl recalled
Pharmedium Services is recalling 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium, 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
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-1395-2016
- 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
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
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
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
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?
Service Code 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 ; Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 ; Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 ; Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 ; Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 ; Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 ; Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 ; Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 ; Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 ; Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 ; Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 ; Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 ; Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160660249M , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160750261M , Exp. Date 6/8/2016 ; Service Code 3V8703 , Lot Number 160800218M , Exp. Date 6/13/2016 ; Service Code 3V8703 , Lot Number 160910144M , Exp. Date 6/24/2016 ; Service Code 3V8703 , Lot Number 160940249M , Exp. Date 6/27/2016 ; Service Code 3V8703 , Lot Number 161080258M , Exp. Date 7/11/2016 ; Service Code 2C8201 , Lot Number 160960246M , Exp. Date 5/21/2016 ; Service Code 2H8122 , Lot Number 160400260M , Exp. Date 5/6/2016 ; Service Code 2H8122 , Lot Number 160460244M , Exp. Date 5/12/2016 ; Service Code 2H8122 , Lot Number 160530172M , Exp. Date 5/19/2016 ; Service Code 2H8122 , Lot Number 160600231M , Exp. Date 5/26/2016 ; Service Code 2H8122 , Lot Number 160610162M , Exp. Date 5/27/2016 ; Service Code 2H8122 , Lot Number 160660246M , Exp. Date 6/1/2016 ; Service Code 2H8122 , Lot Number 160680217M , Exp. Date 6/3/2016 ; Service Code 2H8122 , Lot Number 160770255M , Exp. Date 6/12/2016 ; Service Code 2H8122 , Lot Number 160800216M , Exp. Date 6/15/2016 ; Service Code 2H8122 , Lot Number 160890198M , Exp. Date 6/24/2016 ; Service Code 2H8122 , Lot Number 160910120M , Exp. Date 6/26/2016 ; Service Code 2H8122 , Lot Number 160940211M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160390320M , Exp. Date 5/9/2016 ; Service Code 2H8131 , Lot Number 160460041M , Exp. Date 5/16/2016 ; Service Code 2H8131 , Lot Number 160480170M , Exp. Date 5/18/2016 ; Service Code 2H8131 , Lot Number 160530268M , Exp. Date 5/23/2016 ; Service Code 2H8131 , Lot Number 160600043M , Exp. Date 5/30/2016 ; Service Code 2H8131 , Lot Number 160660087M , Exp. Date 6/5/2016 ; Service Code 2H8131 , Lot Number 160700178M , Exp. Date 6/9/2016 ; Service Code 2H8131 , Lot Number 160750035M , Exp. Date 6/14/2016 ; Service Code 2H8131 , Lot Number 160810269M , Exp. Date 6/20/2016 ; Service Code 2H8131 , Lot Number 160870108M , Exp. Date 6/26/2016 ; Service Code 2H8131 , Lot Number 160900326M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160960059M , Exp. Date 7/5/2016 ; Service Code 2H8201 , Lot Number 160600054M , Exp. Date 5/16/2016 ; Service Code 2H8201 , Lot Number 160670235M , Exp. Date 5/23/2016 ; Service Code 2H8201 , Lot Number 160740184M , Exp. Date 5/30/2016 ; Service Code 2H8201 , Lot Number 160890267M , Exp. Date 6/14/2016 ; Service Code 2H8201 , Lot Number 160950054M , Exp. Date 6/19/2016 ; Service Code 2H8201 , Lot Number 160960004M , Exp. Date 6/20/2016 ; Service Code 2K8122 , Lot Number 160410134M , Exp. Date 5/7/2016 ; Service Code 2K8122 , Lot Number 160460125M , Exp. Date 5/12/2016 ; Service Code 2K8122 , Lot Number 160520111M , Exp. Date 5/17/2016 ; Service Code 2K8122 , Lot Number 160620030M , Exp. Date 5/27/2016 ; Service Code 2K8122 , Lot Number 160670147M , Exp. Date 6/2/2016 ; Service Code 2K8122 , Lot Number 160740165M , Exp. Date 6/9/2016 ; Service Code 2K8122 , Lot Number 160820129M , Exp. Date 6/17/2016 ; Service Code 2K8122 , Lot Number 160900134M , Exp. Date 6/25/2016 ; Service Code 2K8122 , Lot Number 160960144M , Exp. Date 7/1/2016 ; Service Code 2K8123 , Lot Number 160420053C , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160420252M , Exp. Date 5/12/2016 ; Service Code 2K8123 , Lot Number 160450066C , Exp. Date 5/15/2016 ; Service Code 2K8123 , Lot Number 160460028M , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160460061C , Exp. Date 5/16/2016 ; Service Code 2K8123 , Lot Number 160530266M , Exp. Date 5/23/2016 ; Service Code 2K8123 , Lot Number 160550023C , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160550048M , Exp. Date 5/25/2016 ; Service Code 2K8123 , Lot Number 160600017C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600018C , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160600092M , Exp. Date 5/30/2016 ; Service Code 2K8123 , Lot Number 160630013C , Exp. Date 6/2/2016 ; Service Code 2K8123 , Lot Number 160660086M , Exp. Date 6/5/2016 ; Service Code 2K8123 , Lot Number 160670048C , Exp. Date 6/6/2016 ; Service Code 2K8123 , Lot Number 160680061M , Exp. Date 6/7/2016 ; Service Code 2K8123 , Lot Number 160730009C , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160730347M , Exp. Date 6/12/2016 ; Service Code 2K8123 , Lot Number 160740056C , Exp. Date 6/13/2016 ; Service Code 2K8123 , Lot Number 160770021C , Exp. Date 6/16/2016 ; Service Code 2K8123 , Lot Number 160810032M , Exp. Date 6/20/2016 ; Service Code 2K8123 , Lot Number 160820031C , Exp. Date 6/21/2016 ; Service Code 2K8123 , Lot Number 160840046C , Exp. Date 6/23/2016 ; Service Code 2K8123 , Lot Number 160870061C , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160870106M , Exp. Date 6/26/2016 ; Service Code 2K8123 , Lot Number 160880344M , Exp. Date 6/27/2016 ; Service Code 2K8123 , Lot Number 160890065C , Exp. Date 6/28/2016 ; Service Code 2K8123 , Lot Number 160900152C , Exp. Date 6/29/2016 ; Service Code 2K8123 , Lot Number 160910037M , Exp. Date 6/30/2016 ; Service Code 2K8123 , Lot Number 160970069C , Exp. Date 7/6/2016 ; Service Code 2K8123 , Lot Number 161080082M , Exp. Date 7/17/2016 ; Service Code 2K8131 , Lot Number 160420213M , Exp. Date 5/6/2016 ; Service Code 2K8131 , Lot Number 160450363M , Exp. Date 5/9/2016 ; Service Code 2K8131 , Lot Number 160460066C , Exp. Date 5/10/2016 ; Service Code 2K8131 , Lot Number 160480027C , Exp. Date 5/12/2016 ; Service Code 2K8131 , Lot Number 160490047M , Exp. Date 5/13/2016 ; Service Code 2K8131 , Lot Number 160520063C , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160520294M , Exp. Date 5/16/2016 ; Service Code 2K8131 , Lot Number 160540021C , Exp. Date 5/18/2016 ; Service Code 2K8131 , Lot Number 160550019C , Exp. Date 5/19/2016 ; Service Code 2K8131 , Lot Number 160560035M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160560316M , Exp. Date 5/20/2016 ; Service Code 2K8131 , Lot Number 160590127M , Exp. Date 5/23/2016 ; Service Code 2K8131 , Lot Number 160600045C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160600046C , Exp. Date 5/24/2016 ; Service Code 2K8131 , Lot Number 160610014C , Exp. Date 5/25/2016 ; Service Code 2K8131 , Lot Number 160620014C , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620054M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160620322M , Exp. Date 5/26/2016 ; Service Code 2K8131 , Lot Number 160660017C , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160660351M , Exp. Date 5/30/2016 ; Service Code 2K8131 , Lot Number 160680014C , Exp. Date 6/1/2016 ; Service Code 2K8131 , Lot Number 160690285M , Exp. Date 6/2/2016 ; Service Code 2K8131 , Lot Number 160740034M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740052C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740053C , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160740054M , Exp. Date 6/7/2016 ; Service Code 2K8131 , Lot Number 160750021C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160750022C , Exp. Date 6/8/2016 ; Service Code 2K8131 , Lot Number 160760160M , Exp. Date 6/9/2016 ; Service Code 2K8131 , Lot Number 160770323M , Exp. Date 6/10/2016 ; Service Code 2K8131 , Lot Number 160800013C , Exp. Date 6/13/2016 ; Service Code 2K8131 , Lot Number 160810023C , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160810237M , Exp. Date 6/14/2016 ; Service Code 2K8131 , Lot Number 160820054C , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820197M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160820326M , Exp. Date 6/15/2016 ; Service Code 2K8131 , Lot Number 160840065C , Exp. Date 6/17/2016 ; Service Code 2K8131 , Lot Number 160870069C , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160870116M , Exp. Date 6/20/2016 ; Service Code 2K8131 , Lot Number 160880063M , Exp. Date 6/21/2016 ; Service Code 2K8131 , Lot Number 160890015C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160890016C , Exp. Date 6/22/2016 ; Service Code 2K8131 , Lot Number 160900153C , Exp. Date 6/23/2016 ; Service Code 2K8131 , Lot Number 160910051M , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910056C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160910058C , Exp. Date 6/24/2016 ; Service Code 2K8131 , Lot Number 160940330M , Exp. Date 6/27/2016 ; Service Code 2K8131 , Lot Number 160950078M , Exp. Date 6/28/2016 ; Service Code 2K8131 , Lot Number 160960081C , Exp. Date 6/29/2016 ; Service Code 2K8201 , Lot Number 160420343M , Exp. Date 5/6/2016 ; Service Code 2K8201 , Lot Number 160460032M , Exp. Date 5/10/2016 ; Service Code 2K8201 , Lot Number 160520042M , Exp. Date 5/16/2016 ; Service Code 2K8201 , Lot Number 160540340M , Exp. Date 5/18/2016 ; Service Code 2K8201 , Lot Number 160600069M , Exp. Date 5/24/2016 ; Service Code 2K8201 , Lot Number 160630027M , Exp. Date 5/27/2016 ; Service Code 2K8201 , Lot Number 160670025M , Exp. Date 5/31/2016 ; Service Code 2K8201 , Lot Number 160680233M , Exp. Date 6/1/2016 ; Service Code 2K8201 , Lot Number 160740055M , Exp. Date 6/7/2016 ; Service Code 2K8201 , Lot Number 160810363M , Exp. Date 6/14/2016 ; Service Code 2K8201 , Lot Number 160870338M , Exp. Date 6/20/2016 ; Service Code 2K8201 , Lot Number 160890369M , Exp. Date 6/22/2016 ; Service Code 2K8201 , Lot Number 160950065M , Exp. Date 6/28/2016 ; Service Code 2K8442 , Lot Number 160460152M , Exp. Date 5/16/2016 ; Service Code 2K8442 , Lot Number 160600211M , Exp. Date 5/30/2016 ; Service Code 2K8442 , Lot Number 160610241M , Exp. Date 5/31/2016 ; Service Code 2K8442 , Lot Number 160740025M , Exp. Date 6/12/2016 ; Service Code 2K8442 , Lot Number 160750036M , Exp. Date 6/13/2016 ; Service Code 2K8442 , Lot Number 160960031M , Exp. Date 7/4/2016 ; Service Code 2K8442 , Lot Number 160970164M , Exp. Date 7/6/2016 ; Service Code 2K8490 , Lot Number 160390239M , Exp. Date 5/9/2016 ; Service Code 2K8490 , Lot Number 160490196M , Exp. Date 5/19/2016 ; Service Code 2K8490 , Lot Number 160660230M , Exp. Date 6/5/2016 ; Service Code 2K8490 , Lot Number 160770205M , Exp. Date 6/16/2016 ; Service Code 2K8490 , Lot Number 160800075M , Exp. Date 6/18/2016 ; Service Code 2K8490 , Lot Number 160810294M , Exp. Date 6/20/2016 ; Service Code 2K8490 , Lot Number 160870081M , Exp. Date 6/25/2016 ; Service Code 2K8490 , Lot Number 160950212M , Exp. Date 7/4/2016 ; Service Code 2K8689 , Lot Number 160410030M , Exp. Date 5/11/2016 ; Service Code 2K8689 , Lot Number 160490223M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160490224M , Exp. Date 5/19/2016 ; Service Code 2K8689 , Lot Number 160540249M , Exp. Date 5/24/2016 ; Service Code 2K8689 , Lot Number 160620023M , Exp. Date 6/1/2016 ; Service Code 2K8689 , Lot Number 160660089M , Exp. Date 6/5/2016 ; Service Code 2K8689 , Lot Number 160680047M , Exp. Date 6/7/2016 ; Service Code 2K8689 , Lot Number 160730106M , Exp. Date 6/12/2016 ; Service Code 2K8689 , Lot Number 160760117M , Exp. Date 6/15/2016 ; Service Code 2K8689 , Lot Number 160820242M , Exp. Date 6/21/2016 ; Service Code 2K8689 , Lot Number 160870104M , Exp. Date 6/26/2016 ; Service Code 2K8689 , Lot Number 160890215M , Exp. Date 6/28/2016 ; Service Code 2K8689 , Lot Number 160950253M , Exp. Date 7/4/2016 ; Service Code 2K8803 , Lot Number 160530173M , Exp. Date 5/14/2016 ; Service Code 2K8803 , Lot Number 160740149M , Exp. Date 6/3/2016 ; Service Code 2K8803 , Lot Number 160800061M , Exp. Date 6/9/2016 ; Service Code 2K8803 , Lot Number 160880170M , Exp. Date 6/18/2016 ; Service Code 2K8803 , Lot Number 160950144M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160450088M , Exp. Date 5/6/2016 ; Service Code 2K8804 , Lot Number 160460252M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460253M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460326M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160460327M , Exp. Date 5/7/2016 ; Service Code 2K8804 , Lot Number 160490316M , Exp. Date 5/10/2016 ; Service Code 2K8804 , Lot Number 160530032M , Exp. Date 5/14/2016 ; Service Code 2K8804 , Lot Number 160540051M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160540322M , Exp. Date 5/15/2016 ; Service Code 2K8804 , Lot Number 160560041M , Exp. Date 5/17/2016 ; Service Code 2K8804 , Lot Number 160590207M , Exp. Date 5/20/2016 ; Service Code 2K8804 , Lot Number 160610081M , Exp. Date 5/22/2016 ; Service Code 2K8804 , Lot Number 160620295M , Exp. Date 5/23/2016 ; Service Code 2K8804 , Lot Number 160630295M , Exp. Date 5/24/2016 ; Service Code 2K8804 , Lot Number 160660081M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160660333M , Exp. Date 5/27/2016 ; Service Code 2K8804 , Lot Number 160680329M , Exp. Date 5/29/2016 ; Service Code 2K8804 , Lot Number 160700057M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160700292M , Exp. Date 5/31/2016 ; Service Code 2K8804 , Lot Number 160730339M , Exp. Date 6/3/2016 ; Service Code 2K8804 , Lot Number 160750066M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160750317M , Exp. Date 6/5/2016 ; Service Code 2K8804 , Lot Number 160760268M , Exp. Date 6/6/2016 ; Service Code 2K8804 , Lot Number 160800101M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160800160M , Exp. Date 6/10/2016 ; Service Code 2K8804 , Lot Number 160810346M , Exp. Date 6/11/2016 ; Service Code 2K8804 , Lot Number 160820068M , Exp. Date 6/12/2016 ; Service Code 2K8804 , Lot Number 160840051M , Exp. Date 6/14/2016 ; Service Code 2K8804 , Lot Number 160870208M , Exp. Date 6/17/2016 ; Service Code 2K8804 , Lot Number 160890078M , Exp. Date 6/19/2016 ; Service Code 2K8804 , Lot Number 160910299M , Exp. Date 6/21/2016 ; Service Code 2K8804 , Lot Number 160940088M , Exp. Date 6/24/2016 ; Service Code 2K8804 , Lot Number 160950306M , Exp. Date 6/25/2016 ; Service Code 2K8804 , Lot Number 160960068M , Exp. Date 6/26/2016 ; Service Code 2K8804 , Lot Number 161080069M , Exp. Date 7/8/2016 ; Service Code 2K8804 , Lot Number 161080185M , Exp. Date 7/8/2016 ; Service Code 2K8863 , Lot Number 160480267M , Exp. Date 5/9/2016 ; Service Code 2K8863 , Lot Number 160600342M , Exp. Date 5/21/2016 ; Service Code 2K8863 , Lot Number 160620124M , Exp. Date 5/23/2016 ; Service Code 2K8863 , Lot Number 160740265M , Exp. Date 6/4/2016 ; Service Code 2K8863 , Lot Number 160800219M , Exp. Date 6/10/2016 ; Service Code 2K8863 , Lot Number 160870249M , Exp. Date 6/17/2016 ; Service Code 2K8863 , Lot Number 160900028M , Exp. Date 6/20/2016 ; Service Code 2K8863 , Lot Number 160940251M , Exp. Date 6/24/2016 ; Service Code 2K8869 , Lot Number 160450345M , Exp. Date 5/6/2016 ; Service Code 2K8869 , Lot Number 160490074M , Exp. Date 5/9/2016 ; Service Code 2K8869 , Lot Number 160520286M , Exp. Date 5/13/2016 ; Service Code 2K8869 , Lot Number 160550062M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160550302M , Exp. Date 5/16/2016 ; Service Code 2K8869 , Lot Number 160560045M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160560296M , Exp. Date 5/17/2016 ; Service Code 2K8869 , Lot Number 160610328M , Exp. Date 5/22/2016 ; Service Code 2K8869 , Lot Number 160620303M , Exp. Date 5/23/2016 ; Service Code 2K8869 , Lot Number 160660339M , Exp. Date 5/27/2016 ; Service Code 2K8869 , Lot Number 160670066C , Exp. Date 5/28/2016 ; Service Code 2K8869 , Lot Number 160680192M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160680334M , Exp. Date 5/29/2016 ; Service Code 2K8869 , Lot Number 160700296M , Exp. Date 5/31/2016 ; Service Code 2K8869 , Lot Number 160730341M , Exp. Date 6/3/2016 ; Service Code 2K8869 , Lot Number 160750162M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160750323M , Exp. Date 6/5/2016 ; Service Code 2K8869 , Lot Number 160800291M , Exp. Date 6/10/2016 ; Service Code 2K8869 , Lot Number 160820169M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160820170M , Exp. Date 6/12/2016 ; Service Code 2K8869 , Lot Number 160830303M , Exp. Date 6/13/2016 ; Service Code 2K8869 , Lot Number 160840182M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160840296M , Exp. Date 6/14/2016 ; Service Code 2K8869 , Lot Number 160880338M , Exp. Date 6/18/2016 ; Service Code 2K8869 , Lot Number 160900301M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160900302M , Exp. Date 6/20/2016 ; Service Code 2K8869 , Lot Number 160950025C , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160950311M , Exp. Date 6/25/2016 ; Service Code 2K8869 , Lot Number 160960308M , Exp. Date 6/26/2016 ; Service Code 2K8869 , Lot Number 160970273M , Exp. Date 6/27/2016 ; Service Code 2K8869 , Lot Number 161080193M , Exp. Date 7/8/2016 ; Service Code 2K9201 , Lot Number 160490243M , Exp. Date 5/19/2016 ; Service Code 2T6122 , Lot Number 160830171M , Exp. Date 6/22/2016 ; Service Code 2T6122 , Lot Number 160950184M , Exp. Date 7/4/2016 ; Service Code 2T8201 , Lot Number 160960288M , Exp. Date 5/6/2016 ; Service Code 2T8201 , Lot Number 161080318M , Exp. Date 5/18/2016 ; Service Code 2T8869 , Lot Number 160960048C , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160960289M , Exp. Date 5/6/2016 ; Service Code 2T8869 , Lot Number 160970071M , Exp. Date 5/7/2016 ;
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 74057This 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.
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