CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
8 mcg/mL HYDROmorphone HCl and 05% Bupivacaine HCl recalled
Pharmedium Services is recalling 8 mcg/mL HYDROmorphone HCl and 05% Bupivacaine HCl (Preservative Free) in 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-1434-2016
- 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
8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
Where it was distributed
Nationwide
Questions about this recall
Is 8 mcg/mL HYDROmorphone HCl and 05% Bupivacaine HCl (Preservative Free) in 9% Sodium recalled?
Yes. Pharmedium Services recalled 8 mcg/mL HYDROmorphone HCl and 05% Bupivacaine HCl (Preservative Free) in 9% Sodium on 5 May 2016. The recall is Class II and its status is Terminated. Recall number D-1434-2016.
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 160390094M , Exp. Date 5/9/2016 ; Lot Number 160450111M , Exp. Date 5/15/2016 ; Lot Number 160520101M , Exp. Date 5/22/2016 ; Lot Number 160550109M , Exp. Date 5/25/2016 ; Lot Number 160610124M , Exp. Date 5/31/2016 ; Lot Number 160620115M , Exp. Date 6/1/2016 ; Lot Number 160670036M , Exp. Date 6/5/2016 ; Lot Number 160680038M , Exp. Date 6/7/2016 ; Lot Number 160690110M , Exp. Date 6/7/2016 ; Lot Number 160740117M , Exp. Date 6/12/2016 ; Lot Number 160760109M , Exp. Date 6/15/2016 ; Lot Number 160820103M , Exp. Date 6/21/2016 ; Lot Number 160830107M , Exp. Date 6/22/2016 ; Lot Number 160900032M , Exp. Date 6/29/2016 ; Lot Number 160970021M , Exp. Date 7/6/2016 ;
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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