CLASS III Drug recall · Reported 3 Jan 2018 · FDA Enforcement Report
HYDROmorphone HCl in 9% Sodium Chloride Injection Total recalled
Pharmedium Services is recalling HYDROmorphone HCl in 9% Sodium Chloride Injection Total Volume 1 mg per mL, For IV Use, distributed nationwide in the US. The recall was initiated on 26 Sep 2017 and the FDA has classified it as Class III.
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-0132-2018
- FDA event ID
- 78694
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Sep 2017
- FDA classified
- 22 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 26 Sep 2017 | Recall initiated by company | |
| 22 Dec 2017 | Classified by FDA | +87 days |
| 3 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp. Date
Product as listed by the FDA
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Where it was distributed
Nationwide.
Questions about this recall
Is HYDROmorphone HCl in 9% Sodium Chloride Injection Total Volume 1 mg per mL, For IV Use recalled?
Yes. Pharmedium Services recalled HYDROmorphone HCl in 9% Sodium Chloride Injection Total Volume 1 mg per mL, For IV Use on 26 Sep 2017. The recall is Class III and its status is Terminated. Recall number D-0132-2018.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp. Date
Which lots are affected?
Lot: 172410025C; Exp. 11/27/2017
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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