CeFAZolin 1 GM a) in NS 100 mL bag
Medicine recall D-1224-2019. Published in FDA’s Enforcement Report on May 1, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 1, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- North Carolina the one state its words name
- a) 150 bags; b)1369 syringes how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Lack of sterility assurance.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
a) 150 bags; b)1369 syringes, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp. 4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019;…
Every code shown here, 755 characters
Lots: a) ED051904 Exp. 4/14/2019; ED081903 Exp. 4/17/2019; ED091903 Exp. 4/18/2019; ED111903 Exp. 4/20/2019; b) EB271904 Exp. 4/13/2019; EB281904 Exp. 4/14/2019; EC011903 Exp. 4/15/2019; EC051904 Exp. 4/19/2019; EC071904 Exp. 4/21/2019; EC081905 Exp. 4/22/2019; EC121905 Exp. 4/26/2019; EC131903 Exp. 4/27/2019; EC141903 Exp. 4/28/2019; EC151903 Exp. 4/29/2019; EC181904 Exp. 5/2/2019; EC191905 Exp. 5/3/2019; EC211904 Exp. 5/5/2019; EC221905 Exp. 5/6/2019; EC251904 Exp. 5/9/2019; EC271904 Exp. 5/11/2019; EC281904 Exp. 5/12/2019; ED011904 Exp. 5/16/2019; ED021906 Exp. 5/17/2019; ED031904 Exp. 5/18/2019; ED041903 Exp. 5/19/2019; ED051905 Exp. 5/20/2019; ED081904 Exp. 5/23/2019; ED091904 Exp. 5/24/2019; ED101904 Exp. 5/25/2019; ED111904 Exp. 5/26/2019
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
NC
The states and territories these words name
- North Carolina
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 12, 2019.
- FDA classified it on Apr 23, 2019.
- FDA’s Enforcement Report published it on May 1, 2019.
- FDA terminated it on Oct 30, 2019.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CMC Enterprise Pharmacy, of Charlotte, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.