CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled
Pharmedium Services is recalling 3 mcg/mL Fentanyl Citrate and 0.125% 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-1416-2016
- 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
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), 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 3V8708 , Lot Number 160410168M , Exp. Date 5/11/2016 ; Service Code 3V8708 , Lot Number 160600286M , Exp. Date 5/30/2016 ; Service Code 3V8708 , Lot Number 160810284M , Exp. Date 6/20/2016 ; Service Code 3V8708 , Lot Number 160820091M , Exp. Date 6/20/2016 ; Service Code 2H8285 , Lot Number 160470170M , Exp. Date 5/13/2016 ; Service Code 2H8285 , Lot Number 160530182M , Exp. Date 5/19/2016 ; Service Code 2H8285 , Lot Number 160600296M , Exp. Date 5/26/2016 ; Service Code 2H8285 , Lot Number 160670185M , Exp. Date 6/2/2016 ; Service Code 2H8285 , Lot Number 160740253M , Exp. Date 6/9/2016 ; Service Code 2H8285 , Lot Number 160820206M , Exp. Date 6/17/2016 ; Service Code 2H8285 , Lot Number 160880254M , Exp. Date 6/23/2016 ; Service Code 2H8285 , Lot Number 160910152M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160400261M , Exp. Date 5/10/2016 ; Service Code 2K8237 , Lot Number 160450263M , Exp. Date 5/15/2016 ; Service Code 2K8237 , Lot Number 160540239M , Exp. Date 5/24/2016 ; Service Code 2K8237 , Lot Number 160620203M , Exp. Date 6/1/2016 ; Service Code 2K8237 , Lot Number 160700152M , Exp. Date 6/9/2016 ; Service Code 2K8237 , Lot Number 160730269M , Exp. Date 6/12/2016 ; Service Code 2K8237 , Lot Number 160760207M , Exp. Date 6/15/2016 ; Service Code 2K8237 , Lot Number 160810315M , Exp. Date 6/20/2016 ; Service Code 2K8237 , Lot Number 160870248M , Exp. Date 6/26/2016 ; Service Code 2K8237 , Lot Number 160940250M , Exp. Date 7/3/2016 ; Service Code 2K8237 , Lot Number 160970220M , Exp. Date 7/6/2016 ; Service Code 2K8643 , Lot Number 160420245M , Exp. Date 5/12/2016 ; Service Code 2K8643 , Lot Number 160470238M , Exp. Date 5/17/2016 ; Service Code 2K8643 , Lot Number 160480261M , Exp. Date 5/18/2016 ; Service Code 2K8643 , Lot Number 160600351M , Exp. Date 5/30/2016 ; Service Code 2K8643 , Lot Number 160700177M , Exp. Date 6/9/2016 ; Service Code 2K8643 , Lot Number 160770260M , Exp. Date 6/16/2016 ; Service Code 2K8643 , Lot Number 160870191M , Exp. Date 6/26/2016 ; Service Code 2K8643 , Lot Number 160910247M , Exp. Date 6/30/2016 ; Service Code 2K8643 , Lot Number 161080279M , Exp. Date 7/17/2016 ; Service Code 2K8837 , Lot Number 160460262M , Exp. Date 5/7/2016 ; Service Code 2K8837 , Lot Number 160530235M , Exp. Date 5/14/2016 ; Service Code 2K8837 , Lot Number 160600335M , Exp. Date 5/21/2016 ; Service Code 2K8837 , Lot Number 160630109M , Exp. Date 5/24/2016 ; Service Code 2K8837 , Lot Number 160740138M , Exp. Date 6/4/2016 ; Service Code 2K8837 , Lot Number 160770249M , Exp. Date 6/7/2016 ; Service Code 2K8837 , Lot Number 160870243M , Exp. Date 6/17/2016 ; Service Code 2K8837 , Lot Number 160880159M , Exp. Date 6/18/2016 ; Service Code 2K8837 , Lot Number 160900184M , Exp. Date 6/20/2016 ; Service Code 2K8837 , Lot Number 160960129M , Exp. Date 6/26/2016 ; Service Code 2K8906 , Lot Number 160480019M , Exp. Date 5/9/2016 ; Service Code 2K8906 , Lot Number 160540174M , Exp. Date 5/15/2016 ; Service Code 2K8906 , Lot Number 160610163M , Exp. Date 5/22/2016 ; Service Code 2K8906 , Lot Number 160700148M , Exp. Date 5/31/2016 ; Service Code 2K8906 , Lot Number 160750221M , Exp. Date 6/5/2016 ; Service Code 2K8906 , Lot Number 160770136M , Exp. Date 6/7/2016 ; Service Code 2K8906 , Lot Number 160820127M , Exp. Date 6/12/2016 ; Service Code 2K8906 , Lot Number 160890210M , Exp. Date 6/19/2016 ; Service Code 2K8906 , Lot Number 160960171M , Exp. Date 6/26/2016 ; Service Code 2K8963 , Lot Number 160550244M , Exp. Date 5/16/2016 ; Service Code 2K8963 , Lot Number 160560180M , Exp. Date 5/17/2016 ; Service Code 2K8963 , Lot Number 160670202M , Exp. Date 5/28/2016 ; Service Code 2K8963 , Lot Number 160750055C , Exp. Date 6/5/2016 ; Service Code 2K8963 , Lot Number 160760031C , Exp. Date 6/6/2016 ; Service Code 2K8963 , Lot Number 160810065C , Exp. Date 6/11/2016 ; Service Code 2K8963 , Lot Number 160820057C , Exp. Date 6/12/2016 ; Service Code 2K8963 , Lot Number 160890042C , Exp. Date 6/19/2016 ; Service Code 2K8963 , Lot Number 160950052C , Exp. Date 6/25/2016 ; Service Code 2K8963 , Lot Number 160950187M , Exp. Date 6/25/2016 ; Service Code 2K8976 , Lot Number 160470034C , Exp. Date 5/8/2016 ; Service Code 2K8976 , Lot Number 160840015C , Exp. Date 6/14/2016 ; Service Code 2K8976 , Lot Number 160880064C , Exp. Date 6/18/2016 ; Service Code 2K9285 , Lot Number 160450032C , Exp. Date 5/9/2016 ; Service Code 2K9285 , Lot Number 160520065C , Exp. Date 5/16/2016 ; Service Code 2K9285 , Lot Number 160630020C , Exp. Date 5/27/2016 ; Service Code 2K9285 , Lot Number 160690030C , Exp. Date 6/2/2016 ; Service Code 2K9285 , Lot Number 160770036C , Exp. Date 6/10/2016 ; Service Code 2K9285 , Lot Number 160840031C , Exp. Date 6/17/2016 ; Service Code 2K9285 , Lot Number 160880075C , Exp. Date 6/21/2016 ;
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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