Drug recall: Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR…
Class I FDA enforcement event 76395. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
SCA Pharmaceuticals started this drug recall on 3 Feb 2017. The firm address in the FDA record is in Little Rock, AR. FDA put the recall in Class I. FDA event 76395 has 7 product records. The first FDA enforcement report date is 12 Apr 2017. The record gives the status Terminated, with the termination date 19 Oct 2017.
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.
U.S. Nationwide
Recalling firm
SCA Pharmaceuticals, Little Rock, AR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0639-2017 | Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40 | 50 bags | Class I | Terminated | 12 Apr 2017 |
| D-0640-2017 | Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59 | 386 bags | Class I | Terminated | 12 Apr 2017 |
| D-0641-2017 | Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59 | 716 bags | Class I | Terminated | 12 Apr 2017 |
| D-0642-2017 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59 | 490 bags | Class I | Terminated | 12 Apr 2017 |
| D-0643-2017 | Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44 | 50 bags | Class I | Terminated | 12 Apr 2017 |
| D-0644-2017 | Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40 | 30 bags | Class I | Terminated | 12 Apr 2017 |
| D-0645-2017 | Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40 | 62 bags | Class I | Terminated | 12 Apr 2017 |
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 I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2017
- 343
- Share of these events in Class I
- 13%
- Product records in this event
- 7Median of the firm: 1
- Events of the firm on the register
- 19
Other events of the firm
Official channels
- FDA enforcement report D-0639-2017The 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 76395. https://recallregister.com/fda/i/76395/. 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:
U.S. Nationwide
- What quantity of product is in FDA event 76395?
- The event has 7 product records. The first record gives this quantity:
50 bags
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 13% of the 343 drug events that started in 2017 are in Class I.