Aidarex Recalls Ceftriaxone for Injection Due to Manufacturing Deviations
Aidarex Pharmaceuticals is recalling Ceftriaxone for Injection due to out-of-specification intermediates during manufacturing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling Ceftriaxone for Injection USP, 250mg/vial, NDC 53217-0117-01. The product was manufactured by Lupin Limited India and packaged by Aidarex Pharmaceuticals. The recall involves Lot 47312-1, which expires in January 2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an out-of-specification (OOS) intermediate was identified in the subsequent processes used to manufacture the final active pharmaceutical ingredient (API).
The affected product was distributed in Indiana and Georgia. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 47312-1
- Exp 01/2018
Distribution
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