CLASS II Drug recall · Reported 23 Mar 2022 · FDA Enforcement Report
Fentanyl 150 mcg/mL Infusion Solution recalled
Family Pharmacy of Statesville is recalling Fentanyl 150 mcg/mL Infusion Solution, distributed in North Carolina. The recall was initiated on 6 Aug 2020 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-0667-2022
- FDA event ID
- 89773
- Recalling firm
- Family Pharmacy of Statesville, Statesville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2020
- FDA classified
- 17 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 6 Aug 2020 | Recall initiated by company | |
| 17 Mar 2022 | Classified by FDA | +588 days |
| 23 Mar 2022 | Published in enforcement report | +6 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
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
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Where it was distributed
NC only
Questions about this recall
Is Fentanyl 150 mcg/mL Infusion Solution recalled?
Yes. Family Pharmacy of Statesville recalled Fentanyl 150 mcg/mL Infusion Solution on 6 Aug 2020. The recall is Class II and its status is Terminated. Recall number D-0667-2022.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 07312020@5 BUD: 8/14/2020
Where was it sold?
NC only
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.