CLASS II Drug recall · Reported 27 Jul 2016 · FDA Enforcement Report
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl recalled
Pharmedium Services is recalling 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9%, 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-1384-2016
- 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
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
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 2T6733 , Lot Number 160560088M , Exp. Date 5/25/2016 ; Service Code 2T6733 , Lot Number 160590097M , Exp. Date 5/28/2016 ; Service Code 2T6733 , Lot Number 160610032M , Exp. Date 5/31/2016 ; Service Code 2T6733 , Lot Number 160630191M , Exp. Date 6/2/2016 ; Service Code 2T6733 , Lot Number 160740251M , Exp. Date 6/13/2016 ; Service Code 2T6733 , Lot Number 160890051M , Exp. Date 6/27/2016 ; Service Code 2T6733 , Lot Number 160910161M , Exp. Date 6/29/2016 ; Service Code 2K8478 , Lot Number 160380039M , Exp. Date 5/8/2016 ; Service Code 2K8478 , Lot Number 160410139M , Exp. Date 5/11/2016 ; Service Code 2K8478 , Lot Number 160450247M , Exp. Date 5/15/2016 ; Service Code 2K8478 , Lot Number 160540145M , Exp. Date 5/24/2016 ; Service Code 2K8478 , Lot Number 160610157M , Exp. Date 5/31/2016 ; Service Code 2K8478 , Lot Number 160660142M , Exp. Date 6/5/2016 ; Service Code 2K8478 , Lot Number 160730262M , Exp. Date 6/12/2016 ; Service Code 2K8478 , Lot Number 160770247M , Exp. Date 6/16/2016 ; Service Code 2K8478 , Lot Number 160810195M , Exp. Date 6/20/2016 ; Service Code 2K8478 , Lot Number 160890161M , Exp. Date 6/28/2016 ; Service Code 2K8478 , Lot Number 160910234M , Exp. Date 6/30/2016 ; Service Code 2K8478 , Lot Number 160940235M , Exp. Date 7/3/2016 ; Service Code 2T8478 , Lot Number 160910132M , Exp. Date 5/7/2016 ; Service Code 2T8478 , Lot Number 160940032C , Exp. Date 5/10/2016 ;
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.
More recalls from Pharmedium Services
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|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
Other Hydromorphone recalls
All 155| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |