CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
All sterile drug preparations remaining within expiry recalled
Intrathecal Compounding Specialist is recalling All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF, distributed nationwide in the US. The recall was initiated on 30 Nov 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-0322-2018
- FDA event ID
- 78669
- Recalling firm
- Intrathecal Compounding Specialist, Scott, LA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2017
- FDA classified
- 4 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 30 Nov 2017 | Recall initiated by company | |
| 4 Feb 2018 | Classified by FDA | +66 days |
| 14 Feb 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
All lots remaining within expiry (BUD between November 15, 2017 and December 16, 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 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
3 other products · FDA event 78669This product is part of a recall event; the main page for the event is All sterile drug preparations remaining within expiry recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide | |
| CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide | |
| CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide |
More recalls from Intrathecal Compounding Specialist
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide |
| Drug | CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide |
| Drug | CLASS II | All sterile drug preparations remaining within expiry recalled | Intrathecal Compounding Specialist | Sterility | Nationwide |