Aidarex Recalls Ceftriaxone Injection Due to CGMP Deviations
Aidarex Pharmaceuticals LLC recalls specific lots of Ceftriaxone for Injection USP due to manufacturing deviations. Check lot numbers and expiration dates.
Lower-risk recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
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What happened, in plain English
Aidarex Pharmaceuticals LLC is recalling one lot of Ceftriaxone for Injection USP, 250mg/vial, because it contains an out-of-specification intermediate in the manufacturing process. This recall is classified as Class III, indicating a remote probability of adverse health consequences. The record does not specify any injuries or symptoms associated with this deviation. Read more at govinfonow.com/recall/42594-aidarex-recalls-ceftriaxone-injection-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42594-aidarex-recalls-ceftriaxone-injection-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-0974-2016
Cite this page
“Aidarex Recalls Ceftriaxone Injection Due to CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42594-aidarex-recalls-ceftriaxone-injection-due-to-cgmp-deviations. Based on FDA recall #D-0974-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2016%22&limit=1).
Why it’s dangerous
The hazard stems from CGMP (Current Good Manufacturing Practice) deviations where an intermediate ingredient did not meet specifications during the manufacturing of the active pharmaceutical ingredient. While this violates quality standards, Class III classification suggests the risk to health is low or remote.
Who’s affected
Patients who received Ceftriaxone for Injection USP from Aidarex Pharmaceuticals LLC between the manufacturing date and the recall announcement on June 1, 2016. The product was distributed in Indiana (IN) and Georgia (GA).
How to tell if you have this one
Look for Ceftriaxone for Injection USP, 250mg/vial, packaged by Aidarex Pharmaceuticals LLC. The specific recalled item has NDC 53217-0117-01 and Lot #47312-1 with an expiration date of 01/2018.
- Brand
Aidarex Pharmaceuticals- Category
Drug
Where it went and when
Where it was distributed
Distributed in Georgia and Indiana.
FDA distribution: “IN, GA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Indiana.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0974-2016 (June 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0974-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.