CLASS II Drug recall · Reported 23 Sep 2015 · FDA Enforcement Report
Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen recalled
The Compounding Pharmacy of America is recalling Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, distributed nationwide in the US. The recall was initiated on 2 Jun 2015 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-1705-2015
- FDA event ID
- 71371
- Recalling firm
- The Compounding Pharmacy of America, Knoxville, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jun 2015
- FDA classified
- 15 Sep 2015
- Reported
- 23 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Blood Pressure Medication
Timeline
| 2 Jun 2015 | Recall initiated by company | |
| 15 Sep 2015 | Classified by FDA | +105 days |
| 23 Sep 2015 | 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
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it was distributed
Nationwide
Questions about this recall
Is Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile recalled?
Yes. The Compounding Pharmacy of America recalled Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile on 2 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1705-2015.
Why was it recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which lots are affected?
All lots distributed between November 2014 and May 2015; 03092015@25, 6/7/2015; 04242015@44, 7/23/2015
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.
More recalls from The Compounding Pharmacy of America
All 383| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection recalled | The Compounding Pharmacy of America | Sterility | SC, TN |
| Drug | CLASS II | Estradiol 4 mg, Sterile Pellet recalled by The Compounding Pharmacy of | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Testosterone 5 mg Pellet, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen recalled | The Compounding Pharmacy of America | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial recalled | The Compounding Pharmacy of America | Sterility | Nationwide |