CLASS II Drug recall · Reported 22 Nov 2017 · FDA Enforcement Report
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection recalled
PharMEDium Services is recalling Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection, distributed in California, Illinois. The recall was initiated on 13 Oct 2017 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-0080-2018
- FDA event ID
- 78503
- Recalling firm
- PharMEDium Services, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2017
- FDA classified
- 14 Nov 2017
- Reported
- 22 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 13 Oct 2017 | Recall initiated by company | |
| 14 Nov 2017 | Classified by FDA | +32 days |
| 22 Nov 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent drug: out of specification result for potency
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
Where it was distributed
CA, IL
Questions about this recall
Why was it recalled?
Superpotent drug: out of specification result for potency
Which lots are affected?
Lot#: 172820134M, Exp 01/18
Where was it sold?
CA, IL
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.
More recalls from PharMEDium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Per Ml recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone HCl 0.5 mg per mL recalled by PharMEDium Services | PharMEDium Services | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCL 1 mg per mL recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |