Drug recall: Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Class II FDA enforcement event 89773. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this drug recall on 6 Aug 2020. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Statesville, NC. FDA put the recall in Class II. FDA event 89773 has 12 product records. The first FDA enforcement report date is 23 Mar 2022. The record gives the status Terminated, with the termination date 15 Aug 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
NC only
Recalling firm
The name is withheld, Statesville, NC.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0656-2022 | Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 2 bags | Class II | Terminated | 23 Mar 2022 |
| D-0657-2022 | Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 4 bags | Class II | Terminated | 23 Mar 2022 |
| D-0658-2022 | Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 1 bag | Class II | Terminated | 23 Mar 2022 |
| D-0659-2022 | Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 1 bag | Class II | Terminated | 23 Mar 2022 |
| D-0660-2022 | Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | 2 vials | Class II | Terminated | 23 Mar 2022 |
| D-0661-2022 | Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | 5 vials | Class II | Terminated | 23 Mar 2022 |
| D-0662-2022 | Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc. | 3 bottles | Class II | Terminated | 23 Mar 2022 |
| D-0663-2022 | Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc. | 8 bags | Class II | Terminated | 23 Mar 2022 |
| D-0664-2022 | Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 3 bags | Class II | Terminated | 23 Mar 2022 |
| D-0665-2022 | Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 1 bag | Class II | Terminated | 23 Mar 2022 |
| D-0666-2022 | Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc. | 5 syringes | Class II | Terminated | 23 Mar 2022 |
| D-0667-2022 | Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | 1 bag | Class II | Terminated | 23 Mar 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2020
- 342
- Share of these events in Class II
- 64%
- Product records in this event
- 12
Official channels
- FDA enforcement report D-0656-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 89773. https://recallregister.com/fda/ii/89773/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
NC only
- What quantity of product is in FDA event 89773?
- The event has 12 product records. The first record gives this quantity:
2 bags
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2020 have the same class?
- 64% of the 342 drug events that started in 2020 are in Class II.